Prostate AdenocarcinomaPhase 2TARGETNCT00589472
Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer
A Phase 2 study testing Bicalutamide, Goserelin Acetate and Laboratory Biomarker Analysis in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 15 sites in United States.
Trial summary
This phase II trial studies how well androgen deprivation therapy and vorinostat followed by radical prostatectomy works in treating patients with prostate cancer that has not spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- Bicalutamide, Goserelin Acetate and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2007to Jun 2010
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation of prostatic adenocarcinoma in 3 or more biopsy cores, of which at least 1 core demonstrates > 30% involvement with tumor; confirmation of localized disease by magnetic resonance imaging (MRI) with endorectal probe if available
- No evidence of distant disease on a:
- Computed tomography (CT) or MRI of the abdomen and pelvis
- Radionuclide bone scan (with plain film or MRI confirmation as clinically indicated)
- Appropriate candidate for radical prostatectomy
- Adequate cardiac function (evidence of cardiac disease should be evaluated to determine appropriateness of patient as a surgical candidate)
Show all 17Show fewer
- Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for radical prostatectomy
- White blood cell (WBC) > 3000/uL
- Platelets > 150,000/uL
- Creatinine < 2 mg/dL
- Serum PSA < 100 ng/mL
- Bilirubin < 1.5 X ULN (institutional upper limits of normal)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2 X ULN
- Karnofsky performance status > 70%
- Willingness to undergo pretreatment transrectal ultrasound-guided prostate needle biopsy (optional)
- Willingness to use adequate contraceptive methods during study therapy and for at least 3 months after completion of therapy
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Evidence of small-cell, transitional-cell, or neuroendocrine pathologic features
- Prior hormonal therapy with (e.g. 5-alpha-reductase inhibitors, gonadotropin hormone releasing analogs, steroids, megestrol acetate, or nonstudy-related antiandrogens), chemotherapy, or herbal medications administered with the intent to treat the patient's malignancy
- Patients on valproic acid (a histone-deacetylase inhibitor) to treat prostate cancer are not eligible
- History of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would compromise compliance with study requirements
- Currently active secondary malignancy (as determined by the treating physician) other than non-melanoma skin cancer
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
M D Anderson Cancer Center
Houston, Texas, 77030
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
UMDNJ - New Jersey Medical School
Newark, New Jersey, 07103
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
UCSF Medical Center-Parnassus
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Neoadjuvant Androgen Depletion in Combination With Vorinostat Followed by Radical Prostatectomy for Localized Prostate Cancer: Total Androgen-Receptor Gene Expression Targeted Therapy (TARGET)
This phase II trial studies how well androgen deprivation therapy and vorinostat followed by radical prostatectomy works in treating patients with prostate cancer that has not spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the rate of pathologic complete response in patients with localized prostate cancer treated with androgen depletion therapy (ADT) and oral vorinostat administered for a minimum of 6 weeks and maximum of 8 weeks before radical prostatectomy.
SECONDARY OBJECTIVES:
- To determine and evaluate pre- and post-treatment levels of prostate-specific antigen (PSA), testosterone, dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA), and dehydroepiandrosterone-dulfate (DHEA-S) in blood.
II. To determine and evaluate pre- and post-treatment levels of testosterone, androstenedione, androstenediol, DHT, DHEA, and DHEA-S in prostate.
III. To determine and evaluate gene and protein expression analysis including androgen receptor (AR) target genes, PSA and TMPRSS2 (transmembrane protease, serine 2), in pre-treatment biopsy and post-treatment radical prostatectomy.
IV. To determine and evaluate exploratory gene microarray analysis. V. To determine and evaluate the safety and tolerability of ADT in combination with vorinostat (SAHA) as assessed by physical examinations, adverse events, and laboratory assessments.
OUTLINE:
Patients receive bicalutamide orally (PO) once daily (QD) for 1 month and leuprolide acetate intramuscularly (IM) or goserelin acetate subcutaneously (SC) once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Being tested
- Bicalutamide, Goserelin Acetate, Laboratory Biomarker Analysis, Leuprolide Acetate, Therapeutic Conventional Surgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex, Cosudex, ICI 176,334, ICI 176334
Given PO
Goserelin AcetateDrug
Also called ZDX, Zoladex
Given SC
Laboratory Biomarker AnalysisOther
Correlative studies
Leuprolide AcetateDrug
Also called A-43818, Abbott 43818, Abbott-43818, Carcinil
Given IM
Therapeutic Conventional SurgeryProcedure or surgery
Undergo radical prostatectomy
VorinostatDrug
Also called L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Antihormone therapy and enzyme inhibitor therapy) | Experimental | Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician. Receives: Drug: Bicalutamide; Drug: Goserelin Acetate; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Procedure: Therapeutic Conventional Surgery; Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response at the Time of Surgery
The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.
Measured: At 12 weeks
Secondary outcomes (6)
Gleason Score
A Gleason score is the sum of two numbers. Pathologist determines where the cancer is most prominent and assigns the primary grade, the secondary grade is assigned based on where the cancer is next most prominent. A score from one to five is assigned for each area based on how aggressive the tumor appears. A tumor with cell that appear close to normal is assigned a low Gleason score (six or below). A tumor with cells that appear clearly different from those of a normal prostate is assigned a high Gleason score (seven or above). A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.
Measured: Baseline
Levels of DHEA in Blood From Radical Prostatectomy Specimens
Measured: Up to 1 year
Levels of DHEA-S in Blood From Radical Prostatectomy Specimens
Measured: Up to 1 year
Levels of DHT in Blood From Radical Prostatectomy Specimens
Measured: Up to 1 year
Levels of PSA in Blood From Radical Prostatectomy Specimens
Measured: Up to 1 year
Levels of Testosterone in Blood From Radical Prostatectomy Specimens
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJun 2010
- Study completionJun 2010
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 Prostate AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan Slovin, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589472
- Sponsor's protocol ID
- NCI-2009-00238
- Other IDs
- NCI-2009-00238, 06-160, MSKCC IRB 06-160, MSKCC-06160, CDR0000579559, 06-160, 7864, N01CM62205
- Acronym
- TARGET
- Status last verified
- Sep 2017
- First submitted
- 20 Dec 2007
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Androgen Depletion in Combination With Vorinostat Followed by Radical Prostatectomy for Localized Prostate Cancer: Total Androgen-Receptor Gene Expression Targeted Therapy (TARGET)
- ClinicalTrials.gov ID
- NCT00589472
- Acronym / sponsor ID
- TARGET / NCI-2009-00238
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well androgen deprivation therapy and vorinostat followed by radical prostatectomy works in treating patients with prostate cancer that has not spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
PRIMARY OBJECTIVES:
- To determine the rate of pathologic complete response in patients with localized prostate cancer treated with androgen depletion therapy (ADT) and oral vorinostat administered for a minimum of 6 weeks and maximum of 8 weeks before radical prostatectomy.
SECONDARY OBJECTIVES:
- To determine and evaluate pre- and post-treatment levels of prostate-specific antigen (PSA), testosterone, dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA), and dehydroepiandrosterone-dulfate (DHEA-S) in blood.
II. To determine and evaluate pre- and post-treatment levels of testosterone, androstenedione, androstenediol, DHT, DHEA, and DHEA-S in prostate.
III. To determine and evaluate gene and protein expression analysis including androgen receptor (AR) target genes, PSA and TMPRSS2 (transmembrane protease, serine 2), in pre-treatment biopsy and post-treatment radical prostatectomy.
IV. To determine and evaluate exploratory gene microarray analysis. V. To determine and evaluate the safety and tolerability of ADT in combination with vorinostat (SAHA) as assessed by physical examinations, adverse events, and laboratory assessments.
OUTLINE:
Patients receive bicalutamide orally (PO) once daily (QD) for 1 month and leuprolide acetate intramuscularly (IM) or goserelin acetate subcutaneously (SC) once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Antihormone therapy and enzyme inhibitor therapy) | Experimental | Drug: Bicalutamide, Drug: Goserelin Acetate, Other: Laboratory Biomarker Analysis, Drug: Leuprolide Acetate, Procedure: Therapeutic Conventional Surgery, Drug: VorinostatPatients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologic documentation of prostatic adenocarcinoma in 3 or more biopsy cores, of which at least 1 core demonstrates > 30% involvement with tumor; confirmation of localized disease by magnetic resonance imaging (MRI) with endorectal probe if available
- No evidence of distant disease on a:
- Appropriate candidate for radical prostatectomy
- White blood cell (WBC) > 3000/uL
- Platelets > 150,000/uL
Key exclusion criteria (6 listed)
- Evidence of small-cell, transitional-cell, or neuroendocrine pathologic features
- Prior hormonal therapy with (e.g. 5-alpha-reductase inhibitors, gonadotropin hormone releasing analogs, steroids, megestrol acetate, or nonstudy-related antiandrogens), chemotherapy, or herbal medications administered with the intent to treat the patient's malignancy
- History of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would compromise compliance with study requirements
- Currently active secondary malignancy (as determined by the treating physician) other than non-melanoma skin cancer
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 |
|---|---|---|
| BicalutamideAlso: Casodex, Cosudex, ICI 176,334, ICI 176334Given PO | Drug | Treatment (Antihormone therapy and enzyme inhibitor therapy) |
| Goserelin AcetateAlso: ZDX, ZoladexGiven SC | Drug | Treatment (Antihormone therapy and enzyme inhibitor therapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (Antihormone therapy and enzyme inhibitor therapy) |
| Leuprolide AcetateAlso: A-43818, Abbott 43818, Abbott-43818, CarcinilGiven IM | Drug | Treatment (Antihormone therapy and enzyme inhibitor therapy) |
| Therapeutic Conventional SurgeryUndergo radical prostatectomy | Procedure or surgery | Treatment (Antihormone therapy and enzyme inhibitor therapy) |
| VorinostatAlso: L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic AcidGiven PO | Drug | Treatment (Antihormone therapy and enzyme inhibitor therapy) |
Primary outcome
Pathologic Complete Response at the Time of Surgery
Time frame: At 12 weeks
The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.
6 secondary outcomes
Gleason Score
Time frame: Baseline
Levels of DHEA in Blood From Radical Prostatectomy Specimens
Time frame: Up to 1 year
Levels of DHEA-S in Blood From Radical Prostatectomy Specimens
Time frame: Up to 1 year
Levels of DHT in Blood From Radical Prostatectomy Specimens
Time frame: Up to 1 year
Levels of PSA in Blood From Radical Prostatectomy Specimens
Time frame: Up to 1 year
Levels of Testosterone in Blood From Radical Prostatectomy Specimens
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Susan Slovin principal investigator
Memorial Sloan Kettering Cancer Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide, Goserelin Acetate and Laboratory Biomarker Analysis in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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 6 Oct 2017). 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?
Pathologic Complete Response at the Time of Surgery (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2017.