Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Pr… (NCT03070886) | Clinical Trial Compass
CompletedPhase 2/3
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
United States612 participantsStarted 2017-04-05
Plain-language summary
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients post-prostatectomy with baseline Gleason \>= 7 (per prostatectomy pathology)
* Baseline PSA prior to start of androgen deprivation therapy nadir \>= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
* Baseline testosterone level obtained post-prostatectomy prior to start of androgen deprivation therapy and prior to step 1 registration
* Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed within 365 days (1 year) prior to step 1 registrationand any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted; (please note: Prior ablative treatment for benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy \[HIFU\] prior to prostatectomy is allowed)
* Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform
* Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation
* Prior androgen deprivation (luteinizing hormone-releasing hormone \[LHRH\] agonist and/or non-steroidal anti-androgen) is allowed if:
* Androgen deprivation therapy was initiated with…
What they're measuring
1
Freedom from progression (FFP) (Phase II)
Timeframe: From time of randomization to first event, assessed up to 43 months
2
Metastasis free survival (MFS) (Phase III)
Timeframe: From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years