A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Hypofractionated Pelvic Radiation, Brachytherapy Boost, NCCN High-Risk Prostate Cancer, Low-Intermediate Risk Decipher Genomic Score, Androgen Deprivation, 21-405
Eligibility Criteria
Inclusion Criteria:
- Pathologically-proven diagnosis of prostate adenocarcinoma
Clinical stage T3-4 or Gleason score 8-10 or PSA >20 ng/ml
°If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or >90% probability of having T3-T4 disease determined by the reading radiologist.
- Decipher genomic score ≤0.6
- Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
- Age ≥18
- KPS ≥70 or ECOG 0-2
- Estimated life expectancy >5 years
- Baseline prostate volume ≤90 cc
- Baseline IPSS ≤20
- No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
- Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration
Exclusion Criteria:
- Regional lymph node or metastatic disease
- Prior pelvic radiation
- Prior prostate surgery (including TURP or cryosurgery)
- Prior history of inflammatory bowel disease
- Unable to undergo anesthesia or brachytherapy
- Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Arms of the Study
Arm 1
Experimental
Hormone Therapy and Radiation
Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.