Apalutamide in Treating Participants With Prostate Cancer Before Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT03412396|
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma PSA Level Ten to Twenty Stage IIB Prostate Cancer AJCC v8 Testosterone Greater Than 200 ng/dL||Drug: Apalutamide Other: Quality-of-Life Assessment Procedure: Radical Prostatectomy||Phase 2|
I. To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of aggregate pathologic risk features that drive post-operative radiotherapy recommendations from 35% to 15%.
I. To determine the safety and tolerability of 6 months (24 weeks) neoadjuvant apalutamide followed by radical prostatectomy for intermediate risk prostate cancer.
II. To estimate the frequency of clinical complete responses and "near" complete responses (currently defined as < 6 mm total tumor volume).
III. To characterize the molecular features of the treated prostate cancers and link them to morphologic characterization.
IV. To measure the 3-5 year biochemical recurrence rate of treated patients as a baseline to inform a larger phase III trial.
Participants receive apalutamide orally (PO) daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, participants undergo radical prostatectomy.
After completion of study treatment, participants are followed up at 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Study of 6-Months Neoadjuvant Apalutamide Prior to Radical Prostatectomy in Intermediate Risk Patients to Reduce the Frequency of Pathologic Features That Drive Post-Operative Radiation Therapy|
|Actual Study Start Date :||March 22, 2018|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2024|
Experimental: Treatment (apalutamide, radical prostatectomy)
Participants receive apalutamide PO daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, participants undergo radical prostatectomy.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Procedure: Radical Prostatectomy
Undergo radical prostatectomy
Other Name: Prostatovesiculectomy
- Aggregate Pathologic Risk Features [ Time Frame: 2 weeks after last dose of study drug ]Aggregate pathologic risk features defined as any of the 3 pathologic staging features on a radical prostatectomy specimen that indicate elevated future risk of a patient needing pelvic radiation therapy. It can be any single or combination of the three. The three drivers per AUA/ASTRO guidelines are positive surgical margins, extraprostatic extension, and/or seminal vesicle invasion. These will be determined by a single expert genitourinary pathologist. The primary objective is to show a 20% decrease in these aggregate pathologic features.
- Adverse Events (AE_) of Neoadjuvant Apalutamide Followed by Radical Prostatectomy [ Time Frame: Beginning of study drug up to 6 months ]AE scored using CTC AE Version 4.0 for toxicity and adverse event reporting.
- Estimation of the frequency of clinical complete responses (pT0) and "near" complete responses (<6mm total tumor volume) [ Time Frame: 24 weeks up to 1 year after surgery ]The proportion of patients having clinical complete responses and "near" complete responses estimated, along with the exact 95% confidence interval. The Kaplan-Meier method used to assess time to biochemical recurrence and to estimate the rate of biochemical recurrence.
- To characterize the molecular features of the treated prostate cancers and link them to morphologic characterization [ Time Frame: 5 years ]
- Biochemical Recurrence Rate [ Time Frame: 3 to 5 years ]The Kaplan-Meier method used to assess time to biochemical recurrence.
- Quality of Life [ Time Frame: 3 to 5 years ]The EPIC quality of life data summarized by domains and compared pre- and post-treatment using paired t-test or Wilcoxon signed rank test as appropriate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412396
|Contact: John W. Davisemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: John W. Davis 713-792-3250|
|Principal Investigator: John W. Davis|
|Principal Investigator:||John W Davis||M.D. Anderson Cancer Center|