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

University of Michigan Rogel Cancer Center

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Ablative Radiation Therapy; Drug: Hormone therapy or chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03556904

HUM00138918 (Other Identifier)

UMCC 2017.163

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.

Treatment:

Drug: Hormone therapy or chemotherapy

Standard of Care + Ablative Radiation

Experimental group

Description:

Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.

Treatment:

Drug: Hormone therapy or chemotherapy

Radiation: Ablative Radiation Therapy