Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Testing if radiation, hormone therapy, and docetaxel versus radiation and hormone therapy after prostectomy decreases cancer recurrence
Study phase (if other): II and III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
All eligibility criteria below must be met prior to Step 1 Registration
Patients post-prostatectomy with baseline Gleason ? 7 (per prostatectomy pathology)
Baseline PSA nadir ? 0.2 ng/ml (post-operative value is never undetectable) obtained prior to Step 1 registration
Baseline testosterone level obtained post-prostatectomy 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 registration and 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 HIFU prior to prostatectomy is allowed).
Surgical FFPE specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform (See Section 10.1.1 for details).
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 therapy (LHRH agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for ? 90 days duration.
• For example: Patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug. For instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date. For a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date.
• Please note: Finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility.
Pathologically lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx]).
Any pT-stage based on American Joint Committee on Cancer 7th edition is eligible. Study entry will be based on the following diagnostic workup:
• History/physical examination within 60 days prior to Step 1 registration.
• Negative distant metastatic workups:
o A CT scan of the abdomen and pelvis (with contrast [CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy]), or MRI of the abdomen and pelvis with contrast within 120 days prior to Step 1 registration
(Please note: Lymph nodes will be considered negative (N0) if they are < 1.5 cm short axis);
o Bone scan within 120 days prior to Step 1 registration
(Please note: a NaF PET/CT is an acceptable substitute and if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis.).
Age ? 18
ECOG Performance Status of ? 1 within 60 days prior to Step 1 registration
Adequate hematologic function within 60 days prior to Step 1 registration defined as follows and based upon a CBC
• Platelets ? 100,000 cell/mm3;
• Hemoglobin ? 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ? 10.0 g/dl is NOT allowed);
• Absolute neutrophil count ? 1500 cells/mm3.
Adequate hepatic function within 60 days prior to Step 1 registration defined as follows:
• AST or ALT < 1.5 x the upper limit of institutional normal
• Total bilirubin (? 1.5 mg/dl) unless history of Gilbert’s syndrome.
The patient or a legally authorized representative must provide study-specific informed consent prior to Step 1 registration.
Primary disease category: Cancer
Sponsor: NRG Oncology
Projected enrollment dates: July 2017 to July 2020
Official study title: PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL