Adenocarcinoma of the ProstatePhase 2NCT00438464

Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

A Phase 2 study testing Finasteride, Prostatectomy and Laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage II Prostate Cancer, run by National Cancer Institute (NCI) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Adenocarcinoma of the Prostate, Stage II Prostate Cancer
What is being tested?: Finasteride, Prostatectomy and Laboratory biomarker analysis
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 8 sitesUnited States
Study dates: Feb 2007to Apr 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Criteria:

Histologically confirmed adenocarcinoma of the prostate
Clinical stage T1c or T2 (stage II)
Gleason score of 6 or 7 on initial biopsy
Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months
Candidate for and scheduled to undergo prostatectomy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 70-100%
Fertile patients must use effective contraception
No active malignancy at any other site
No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride
No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia
No psychiatric illness or social situation that would preclude study compliance
More than 6 months since prior hormonal agents, including dutasteride or finasteride
More than 6 months since prior chemotherapy
More than 1 month since prior participation in another investigational study
No prior radiotherapy for the primary tumor
No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride
No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
M D Anderson Cancer Center
Houston, Texas, 77030
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, 78209
Cancer Therapy and Research Center
San Antonio, Texas, 78229
University Hospital
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer

Read the detailed description

PRIMARY OBJECTIVES:

Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo.

SECONDARY OBJECTIVES:

Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.

II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.

III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.

IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy.

Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.

Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies.

After completion of study treatment, patients are followed up for 30 days.

Conditions: Adenocarcinoma of the Prostate, Stage II Prostate Cancer
Being tested: Finasteride, Placebo, Prostatectomy, Laboratory biomarker analysis
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FinasterideDrug
Also called Finastid, MK 906, Proscar, Prostide
Given PO
PlaceboOther
Also called PLCB
Given PO
ProstatectomyProcedure or surgery
Also called Radical Prostatectomy, Therapeutic conventional surgery, Simple Prostatectomy
Undergo prostatectomy
Laboratory biomarker analysisOther
Correlative studies

Study groups in NCT00438464
Study group	Role	What they receive
Arm I (Finasteride)	Experimental	Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. Receives: Drug: Finasteride; Procedure: Prostatectomy; Other: Laboratory biomarker analysis
Arm II (Placebo)	Placebo comparator	Placebo once daily for 4-6 weeks, then undergo prostatectomy. Receives: Other: Placebo; Other: Laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.
Measured: At prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Measured: At prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Measured: At prostatectomy following maximum 6 week treatment period.
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Measured: At prostatectomy following maximum 6 week treatment period.

Secondary outcomes (20)

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)
Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus
Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.
Measured: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy
Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)
Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.
Measured: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Measured: At prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Measured: At prostatectomy following maximum 6 week treatment period.
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Measured: At prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Measured: At prostatectomy following maximum 6 week treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Apr 2012

First posted22 Feb 2007 (estimated)
Study startFeb 2007
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00438464
Sponsor's protocol ID: NCI-2009-00856
Other IDs: NCI-2009-00856, CDR0000653463, 2006-0614, MDA03-1-03, N01CN35159, P30CA016672
Status last verified: Jun 2015
First submitted: 20 Feb 2007
Last updated: 9 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma

All Adenocarcinoma of the Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer
ClinicalTrials.gov ID: NCT00438464
Acronym / sponsor ID: NCI-2009-00856
Conditions: Adenocarcinoma of the Prostate, Stage II Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Collaborators: M.D. Anderson Cancer Center
Study start: Feb 2007
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 22 Feb 2007 (estimated)
Results: Posted 9 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo.

SECONDARY OBJECTIVES:

Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.

II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.

III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.

IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy.

Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.

Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies.

After completion of study treatment, patients are followed up for 30 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm I (Finasteride)	Experimental	Drug: Finasteride, Procedure: Prostatectomy, Other: Laboratory biomarker analysisFinasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Arm II (Placebo)	Placebo comparator	Other: Placebo, Other: Laboratory biomarker analysisPlacebo once daily for 4-6 weeks, then undergo prostatectomy.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FinasterideAlso: Finastid, MK 906, Proscar, ProstideGiven PO	Drug	Arm I (Finasteride)
PlaceboAlso: PLCBGiven PO	Other	Arm II (Placebo)
ProstatectomyAlso: Radical Prostatectomy, Therapeutic conventional surgery, Simple ProstatectomyUndergo prostatectomy	Procedure or surgery	Arm I (Finasteride)
Laboratory biomarker analysisCorrelative studies	Other	Arm I (Finasteride), Arm II (Placebo)

Primary outcome

Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Time frame: At prostatectomy following maximum 6 week treatment period
Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Time frame: At prostatectomy following maximum 6 week treatment period
Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Time frame: At prostatectomy following maximum 6 week treatment period.
Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Time frame: At prostatectomy following maximum 6 week treatment period.
Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.

20 secondary outcomes

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
Time frame: At prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
Time frame: At prostatectomy following maximum 6 week treatment period.
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
Time frame: At prostatectomy following maximum 6 week treatment period
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
Time frame: At prostatectomy following maximum 6 week treatment period.

Results and safety

Results posted to the registry on 9 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Finasteride)	103	89
Arm II (Placebo)	101	94

Primary outcome: Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy

Time frame: At prostatectomy following maximum 6 week treatment period. Median (Full Range). Unit: Percentage tumor cell involvement

Measure	Finasteride Arm Within GG3 n = 62	Placebo Arm Within GG3 n = 68
VEGF (N=37,55)	80 (5 to 100)	90 (0 to 100)
ERβ (N=35, 55)	15.0 (0.03 to 59.0)	6.6 (0 to 56.3)
AR (N=35, 54)	75.2 (21.5 to 92.1)	78.3 (33.8 to 97.6)
Ki-67 (N=37,54)	1.1 (0.05 to 5.4)	1.3 (0.03 to 4.5)
SRD5A2 (N=45,47)	100 (0 to 100)	90 (0 to 100)
UBE2C (N=34,55)	0.4 (0 to 1.5)	0.3 (0 to 2.4)
Caspase (N=38,55)	0.2 (0.01 to 4.1)	0.08 (0 to 0.8)

Finasteride Arm Within GG3 vs Placebo Arm Within GG3: p = 0.70, Wilcoxon (Mann-Whitney)
Finasteride Arm Within GG3 vs Placebo Arm Within GG3: p = 0.38, Wilcoxon (Mann-Whitney)
Finasteride Arm Within GG3 vs Placebo Arm Within GG3: p = 0.41, Wilcoxon (Mann-Whitney)

Population analysed: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.

Primary outcome: Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy

Time frame: At prostatectomy following maximum 6 week treatment period. Median (Full Range). Unit: Percentage of tumor cell involvement

Measure	Finasteride Arm Within GG4 n = 62	Placebo Arm Within GG4 n = 68
VEGF (N=48,61)	85 (5 to 100)	70 (0 to 100)
ERβ (N=48,62)	8.0 (0 to 49.6)	9.5 (0 to 72.8)
AR (N=48,62)	63.71 (13.5 to 92.0)	75.9 (1.4 to 96.6)
Ki-67 (N=48,62)	1.3 (0.05 to 7.2)	1.4 (0.05 to 7.3)
SRD5A2 (N=38,69)	95 (0 to 100)	90 (0 to 100)
UBE2C (N=46,62)	0.3 (0 to 1.6)	0.3 (0 to 2.3)
Caspase (N=47,61)	0.06 (0 to 0.5)	0.04 (0 to 0.6)

Finasteride Arm Within GG4 vs Placebo Arm Within GG4: p = 0.45, Wilcoxon (Mann-Whitney)
Finasteride Arm Within GG4 vs Placebo Arm Within GG4: p = 0.83, Wilcoxon (Mann-Whitney)
Finasteride Arm Within GG4 vs Placebo Arm Within GG4: p = 0.04, Wilcoxon (Mann-Whitney)

Primary outcome: Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy

Time frame: At prostatectomy following maximum 6 week treatment period.. Mean (Standard Deviation). Unit: Percentage of tumor cell involvement

Measure	Finasteride Arm Within GG3 n = 62	Placebo Arm Within GG3 n = 68
VEGF (N=37,55)	63.9 (36.3)	63.7 (38)
ERβ (N=35, 55)	18.1 (15.6)	14.8 (14.7)
AR (N=35, 54)	69.8 (17.3)	72.4 (16.7)
Ki-67 (N=37,54)	1.6 (1.4)	1.5 (1.0)
SRD5A2 (N=45,47)	72.9 (37.0)	64.7 (43.7)
UBE2C (N=34,55)	0.5 (0.4)	0.5 (0.5)
Caspase (N=38,55)	0.4 (0.7)	0.2 (0.2)

Primary outcome: Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy

Time frame: At prostatectomy following maximum 6 week treatment period.. Mean (Standard Deviation). Unit: Percentage of tumor cell involvement

Measure	Finasteride Arm Within GG4 n = 62	Placebo Arm Within GG4 n = 68
VEGF (N=48,61)	63.6 (35.5)	59.8 (35.4)
ERβ (N=48,62)	15.0 (15.1)	16.7 (18.8)
AR (N=48,62)	64.3 (16.67)	68.6 (23.1)
Ki-67 (N=48,62)	1.8 (1.6)	1.7 (1.4)
SRD5A2 (N=38,69)	71.8 (37.6)	64.9 (40.8)
UBE2C (N=46,62)	0.5 (0.4)	0.5 (0.4)
Caspase (N=47,61)	0.1 (0.1)	0.06 (0.08)

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: The final collection of adverse events obtained at the completion of the 4-6 week course of study medication/placebo, before prostatectomy. Overall study period: March 2007 to April 2012.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Finasteride)	0 of 89 (0%)	0 of 89 (0%)	Not reported
Arm II (Placebo)	0 of 94 (0%)	0 of 94 (0%)	Not reported

Limitations and caveats (from the sponsor): Predefined molecular signature could not easily distinguish GG 4 from GG 3 tumor areas in the placebo arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Adenocarcinoma of the Prostate

RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeri Kim principal investigator

M.D. Anderson Cancer Center

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy (time frame: At prostatectomy following maximum 6 week treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00438464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.