Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
You may not be if
• Prior local or systemic therapy for prostate cancer (e.g. ADT, chemotherapy or novel Androgen Receptor Inhibitors \[ARIs\]);
* PSMA-PET positive nodal or distant metastases;
* PTEN loss or equivocal by IHC (at least more than 50%);
* Evidence of nodal or distant metastases on conventional imaging;
* Prior pelvic radiation or prostate surgery interfering with RT (except biopsy/TURP);
* Life expectancy \<5 years regardless of the prostate cancer;
* Severe concurrent disease, infection, or co-morbidity that would make the patient inappropriate for enrollment (e.g. cardiovascular disease, hypertension, diabetes, etc);
* Uncontrolled cardiovascular disease including:
* Myocardial infarction within 6 months;
* Unstable angina;
* Congestive Heart Failure: New York Heart Association (NYHA) class III or IV;
* Severe arrhythmia;
* Active severe infection or immunocompromised;
* Active second malignancy within 5 years with the exception of:
* Non-melanoma skin cancer;
* Chronic Lymphocytic Leukemia (CLL) that is stable and not actively treated;
* Any condition compromising adherence to the protocol.
Clareo Health | ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study (PCS XIV)
