Stage III Prostate Adenocarcinoma AJCC v7Phase 2NCT02849990
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy
A Phase 2 study testing Abiraterone Acetate, Apalutamide and Degarelix in people with Stage III Prostate Adenocarcinoma AJCC v7 and Stage III Prostate Cancer AJCC v7, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage III Prostate Adenocarcinoma AJCC v7, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Adenocarcinoma AJCC v7
- What is being tested?
- Abiraterone Acetate, Apalutamide and Degarelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 10 Dec 2020
- 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
Who may be able to join
- Willing and able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Documented histologically confirmed adenocarcinoma of the prostate
- Willing to undergo prostatectomy as primary treatment for localized prostate cancer
- High risk prostate cancer (per National Comprehensive Cancer Network [NCCN] criteria): Gleason score 8-10 or T3a or PSA > 20 ng/mL or very-high risk prostate cancer (per NCCN criteria): T3b-T4
- Serum testosterone >= 150 ng/dL
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- Able to swallow the study drugs whole
- Willing to take abiraterone acetate on an empty stomach (no food should be consumed at least two hours before and for one hour after dosing)
- Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
- Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry
Who cannot join
- Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
- Prior use of apalutamide, abiraterone acetate or degarelix
- Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
- Hormonal therapy (for example [e.g.] leuprolide, goserelin, triptorelin, degarelix)
- Cytochrome P450 (CYP)-17 inhibitors (e.g. ketoconazole)
- Antiandrogens (e.g. bicalutamide, nilutamide)
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- Second generation antiandrogens (e.g. enzalutamide, apalutamide)
- Immunotherapy (e.g. sipuleucel-T, ipilimumab)
- Chemotherapy (e.g. docetaxel, cabazitaxel)
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
- Absolute neutrophil count [ANC] < 1500/mm^3
- Platelet count < 100,000/mm^3
- Hemoglobin < 9 g/dL
- Total bilirubin > 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN; Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
- Abnormal kidney function (glomerular filtration rate GFR < 45 mL/min)
- Serum albumin < 3 g/dL
- Serum potassium < 3.5 mmol/L
- Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
- History of stroke within the last 5-years
- History of gastrointestinal (GI) bleed requiring transfusion
- History of peptic ulcer disease requiring treatment within the last 5-years
- History of asthma that is nonsteroidal anti-inflammatory drug (NSAID)-induced or with asthma that is classified as 'mild-persistent' or worse (based on symptoms occurring more than 2 days per week)
- Uncontrolled hypertension
- Gastrointestinal disorder affecting absorption
- Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/ prednisolone once daily
- Any condition that in the opinion of the investigator, would preclude participation in this study
- Child Pugh class B \& C
- Pre-existing viral hepatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy
This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- The rate of the pathologic complete response (pCR) (i.e. no evidence of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
SECONDARY OBJECTIVES:
- To determine the negative margin rate as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
II. To determine the rate of near pCR (i.e. =< 5 mm of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
III. To determine the rate of pathologic T3 disease as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
IV. To determine the rate of nodal metastases as assessed on surgical lymph node specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
- To determine the apoptotic index (i.e. percentage of tumor cells undergoing apoptosis) as determined by cleaved caspase-3 immunohistochemistry following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
VI. To determine the proportion of men who receive adjuvant radiation therapy within 1-year of prostatectomy.
VII. To determine the biochemical (i.e. prostate-specific antigen [PSA]) progression free survival estimate two years after the last patient has accrued (i.e. confirmed PSA post-radical prostatectomy >= 0.2 ng/mL).
VIII. To determine the overall survival estimate two years after the last patient has accrued.
IX. Safety as assessed by the incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Exploratory biomarker assessment.
OUTLINE:
Patients receive apalutamide and abiraterone acetate orally (PO) daily, prednisone PO twice per day (BID) and indomethacin PO three times per day (TID). Patients also receive degarelix subcutaneously (SC) on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.
After completion of study treatment, patients are followed up at 28, 113, 450 and 815 days.
- Conditions
- Stage III Prostate Adenocarcinoma AJCC v7, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Adenocarcinoma AJCC v7, Stage IV Prostate Cancer AJCC v7
- Being tested
- Abiraterone Acetate, Apalutamide, Degarelix, Indomethacin, 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.
Abiraterone AcetateDrug
Also called CB7630, Zytiga
Given PO
ApalutamideDrug
Also called ARN 509, ARN-509, ARN509, JNJ 56021927
Given PO
DegarelixDrug
Also called FE200486, Firmagon
Given SC
IndomethacinDrug
Also called Indocin, Indometacin
Given PO
Laboratory Biomarker AnalysisOther
Correlative study
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (neoadjuvant chemotherapy) | Experimental | Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85. Receives: Drug: Abiraterone Acetate; Drug: Apalutamide; Drug: Degarelix; Drug: Indomethacin; Other: Laboratory Biomarker Analysis; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H\&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months.
Measured: At 3 months
Secondary outcomes (8)
Apoptotic Index (i.e. Percentage of Tumor Cells Undergoing Apoptosis)
Will be determined by cleaved caspase-3 immunohistochemistry.
Measured: At 3 months
Number of Patients With a Negative Margin After 3 Months of Treatment
The absence of tumor cells at the prostate margin will be assessed using standard pathological practices on prostatectomy specimens (i.e. after 3 months of treatment).
Measured: At 3 months
Overall Survival (OS)
Will will report the number of participants alive at 2-years following enrollment.
Measured: At 2 years
Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment
The near pathologic complete response will be defined as =< 5 mm of residual tumor as assessed on prostatectomy specimens after 3 months of treatment.
Measured: At 3 months
Number of Patients With no Nodal Metastases After 3 Months of Treatment.
The presence of tumor cells within surgically excised lymph nodes will be assessed after 3 months of treament.
Measured: At 3 months
Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.
The presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 3 months of treament.
Measured: At 3 months
Number of Participants Without Biochemical Failure at 2 Years
Prostate-specific antigen progression (i.e. biochemical failure) will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL). We will report the number of patients without biochemical failure at 2 years.
Measured: At 2 years
The Proportion of Men Who Receive Adjuvant Radiation Therapy
Patients that received radiation following prostatetomy
Measured: Up to 1 year post prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start9 Mar 2017
- Primary completion10 Dec 2018
- Study completion10 Dec 2020
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 Stage III Prostate Adenocarcinoma AJCC v7Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael Schweizer, University of Washington
- Investigators
- Michael Schweizer, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849990
- Sponsor's protocol ID
- 9628
- Other IDs
- NCI-2016-01027, 9628, P30CA015704, RG1716056
- Status last verified
- Dec 2021
- First submitted
- 25 Jul 2016
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy
- ClinicalTrials.gov ID
- NCT02849990
- Acronym / sponsor ID
- 9628
- Conditions
- Stage III Prostate Adenocarcinoma AJCC v7, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Adenocarcinoma AJCC v7, Stage IV Prostate Cancer AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, National Cancer Institute (NCI)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Posted 18 Jan 2020
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 apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- The rate of the pathologic complete response (pCR) (i.e. no evidence of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
SECONDARY OBJECTIVES:
- To determine the negative margin rate as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
II. To determine the rate of near pCR (i.e. =< 5 mm of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
III. To determine the rate of pathologic T3 disease as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
IV. To determine the rate of nodal metastases as assessed on surgical lymph node specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
- To determine the apoptotic index (i.e. percentage of tumor cells undergoing apoptosis) as determined by cleaved caspase-3 immunohistochemistry following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.
VI. To determine the proportion of men who receive adjuvant radiation therapy within 1-year of prostatectomy.
VII. To determine the biochemical (i.e. prostate-specific antigen [PSA]) progression free survival estimate two years after the last patient has accrued (i.e. confirmed PSA post-radical prostatectomy >= 0.2 ng/mL).
VIII. To determine the overall survival estimate two years after the last patient has accrued.
IX. Safety as assessed by the incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Exploratory biomarker assessment.
OUTLINE:
Patients receive apalutamide and abiraterone acetate orally (PO) daily, prednisone PO twice per day (BID) and indomethacin PO three times per day (TID). Patients also receive degarelix subcutaneously (SC) on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.
After completion of study treatment, patients are followed up at 28, 113, 450 and 815 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (neoadjuvant chemotherapy) | Experimental | Drug: Abiraterone Acetate, Drug: Apalutamide, Drug: Degarelix, Drug: Indomethacin, Other: Laboratory Biomarker Analysis, Drug: PrednisonePatients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Documented histologically confirmed adenocarcinoma of the prostate
- Willing to undergo prostatectomy as primary treatment for localized prostate cancer
- High risk prostate cancer (per National Comprehensive Cancer Network [NCCN] criteria): Gleason score 8-10 or T3a or PSA > 20 ng/mL or very-high risk prostate cancer (per NCCN criteria): T3b-T4
Key exclusion criteria (32 listed)
- Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
- Prior use of apalutamide, abiraterone acetate or degarelix
- Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
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 |
|---|---|---|
| Abiraterone AcetateAlso: CB7630, ZytigaGiven PO | Drug | Treatment (neoadjuvant chemotherapy) |
| ApalutamideAlso: ARN 509, ARN-509, ARN509, JNJ 56021927Given PO | Drug | Treatment (neoadjuvant chemotherapy) |
| DegarelixAlso: FE200486, FirmagonGiven SC | Drug | Treatment (neoadjuvant chemotherapy) |
| IndomethacinAlso: Indocin, IndometacinGiven PO | Drug | Treatment (neoadjuvant chemotherapy) |
| Laboratory Biomarker AnalysisCorrelative study | Other | Treatment (neoadjuvant chemotherapy) |
| PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven PO | Drug | Treatment (neoadjuvant chemotherapy) |
Primary outcome
Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
Time frame: At 3 months
Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H\&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months.
8 secondary outcomes
Apoptotic Index (i.e. Percentage of Tumor Cells Undergoing Apoptosis)
Time frame: At 3 months
Number of Patients With a Negative Margin After 3 Months of Treatment
Time frame: At 3 months
Overall Survival (OS)
Time frame: At 2 years
Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment
Time frame: At 3 months
Number of Patients With no Nodal Metastases After 3 Months of Treatment.
Time frame: At 3 months
Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.
Time frame: At 3 months
Number of Participants Without Biochemical Failure at 2 Years
Time frame: At 2 years
The Proportion of Men Who Receive Adjuvant Radiation Therapy
Time frame: Up to 1 year post prostatectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- 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.
Michael Schweizer principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone Acetate, Apalutamide and Degarelix in people with Stage III Prostate Adenocarcinoma AJCC v7 and Stage III Prostate Cancer AJCC v7, run by University of Washington at 1 site 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 10 inclusion and 32 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 18 Jan 2020). 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 Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment (time frame: At 3 months). 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 13 Jan 2022.