FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)

FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE): A Phase II Randomized Trial

This clinical trial will determine whether the addition of radiotherapy to standard of care systemic therapy improves objective progression-free survival compared to systemic therapy alone in patients with oligometastatic castration-resistant prostate cancer.

Inclusion Criteria:

• Subjects must have biopsy-confirmed adenocarcinoma of the prostate
• Subjects must discontinue any prior systemic therapies (excluding GnRH agonist/antagonists) without PSA withdrawal effects if using first generation anti-androgens. Luteinizing hormone-releasing hormone (LHRH) analogues must be continued if they have not undergone orchiectomy. (Subjects who recently started systemic therapy for metastatic castration-resistant prostate cancer (mCRPC) are eligible to enroll if new therapy was started ≤ 14 days to consent date.)
• Subjects must have progressive metastatic castration-resistant prostate cancer based on at least one of the following criteria while having castrate levels (<50 ng/dL) of testosterone:
• A) PSA progression defined as a 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval.
• B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT scan or MRI based on RECIST criteria
• C) Progression of bone disease on bone scan as defined by two new lesions arising
• Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field.
• Subjects must be medically fit to undergo radiotherapy and systemic therapy as determined by the treating physician.
• Age ≥ 18
• ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
• No prior invasive malignancy in the past 3-years. Exceptions include non-melanomatous skin cancer and in situ cancers of the bladder or head and neck are permissible.
• Subjects must freely sign informed consent to enroll in the study.
• Subjects must use contraception up to 90 days after last drug dose.

Exclusion Criteria:

• Planned systemic therapy with Radium-223 dichloride or sipuleucel-T
• Tumor requiring emergent radiation in view of provider
• Life expectancy estimate of <3 months
• Presence of known parenchymal brain metastasis
• Uncontrolled intercurrent illness
• Inability to undergo radiotherapy, systemic treatment, CTs or bone scans
• Biopsy proven pure small cell or neuroendocrine prostate cancer