PSA Response-Based Radiation Therapy and Androgen Deprivation Therapy after Surgery for the Treatment of Relapsed Localized Prostate Cancer, RANGER Study

Inclusion Criteria

• Men aged ≥ 18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with post-operative PSA (persistent or rising) of ≥ 0.05ng/mL.
• Radical prostatectomy ≥ 4 months prior to enrollment without nodal involvement (pN0 or pNx).
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
• No definite evidence of regional or distant metastatic disease by at least pelvic imaging within 90 days of registration. Equivocal findings are allowed at investigator discretion. Imaging is specified as follows: * PSA ≥ 0.2ng/mL: positron emission tomography (PET) with Food and Drug Administration (FDA)-approved advanced imaging agent for prostate cancer (e.g. prostate-specific membrane antigen [PSMA]) required. * PSA < 0.2 n/gm: PET with above noted agents OR conventional CT or MRI at investigator discretion.
• All sexually active men must agree to use adequate contraception for the duration of study therapies and a period of 60 days thereafter. Should a female partner of a trial participant become pregnant or suspect she is pregnant while the subject is participating in this study, the patient should inform his treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Prior androgen deprivation therapy (ADT) > 3 months OR anti-androgen therapy (AAT) of > 30 days. For shorter courses of either, at least 30 day “wash out” period is required with confirmation of resolved castration of testosterone to > 50ng/mL.
• Ongoing testosterone replacement therapy (TRT) with refusal to discontinue (must be stopped with demonstration of detectable PSA ≥ 0.05ng/mL and non-castrate testosterone > 50ng/mL after 14 days of TRT cessation).
• Prior pelvic radiotherapy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• History of bladder neck or urethral stricture requiring procedural intervention.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to actively interfere with the safety or efficacy assessments of this study in the investigator’s view.
• Active inflammatory bowel disease requiring recurring systemic or steroid/enema therapy.