Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score
Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score
The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.
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:
Basking Ridge, New Jersey 07920, United States
Middletown, New Jersey 07748, United States
Montvale, New Jersey 07645, United States
Commack, New York 11725, United States
Harrison, New York 10604, United States
New York, New York 10065, United States