Clinical Trials

Inclusion Criteria:

• Gender assigned male at birth: age ≥ 18 years
• Histological confirmation of prostate adenocarcinoma
• National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Ability to complete questionnaire(s) by themselves or with assistance
• Signed informed consent
• Willing to complete requirements for follow-up (during active monitoring phase)

Exclusion Criteria:

• NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
• Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
• Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
• Metastatic disease by conventional or molecular imaging
• Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
• Concurrent antineoplastic agents (chemotherapy)
• Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
• Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
• Prostate gland volume > 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score > 17
• Body weight > 200 kilogram

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/27/2024. Questions regarding updates should be directed to the study team contact.