The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexMale
- Healthy volunteersNo
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate.
- High-risk localized prostate cancer, defined as ≥1 of the following (per National Comprehensive Cancer Network or D'Amico criteria):
- Prostate specific antigen ≥ 20 ng/mL
- Gleason score 8-10
- Clinical stage T3a or higher; imaging can be used to determine T stage if there is macroscopic (gross) extraprostatic extension or invasion of the seminal vesicles or other non-prostate organs
- No evidence of distant metastasis, confirmed by:
- a. Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) or equivalent staging imaging
- Planning to receive definitive external beam radiotherapy and hormone therapy as standard of care (on label or medically accepted) treatment
- Eastern Cooperative Oncology Group performance status 0-1.
- Age ≥ 18 years.
- Willingness to use adequate contraception if sexually active and of reproductive potential
- Ability to understand and willingness to sign informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
You cannot join if
- Evidence of metastatic disease, including nodal disease beyond the pelvis or distant metastases on imaging.
- Clear evidence of regional nodal disease on conventional imaging.
- Prior prostatectomy.
- Prior systemic therapy for prostate cancer, including:
- Androgen deprivation therapy (Note that participants who have started Androgen deprivation therapy within 90 days prior to randomization can be enrolled.)
- Androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
- Chemotherapy for prostate cancer.
- Prior pelvic radiotherapy.
- Any condition that, in the investigator's judgment, would compromise the patient's safety or compliance.
Triangle