Phase 2
N=14
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03556904 ↗Enrolled (actual)
14
Serious AEs
21.4%
Results posted
Jan 2026
Primary outcome: Primary: Median Duration of Response — NA; NA months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ablative Radiation Therapy (Radiation); Hormone therapy or chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Duration of Response |
NA; NA | — |
| SECONDARY Median Objective Progression Free Survival (PFS) Time |
NA; 26 | — |
| SECONDARY Median Prostate Specific Antigen (PSA) PFS |
NA; NA | — |
| SECONDARY Median Radiographic PFS |
NA; 26 | — |
| SECONDARY Overall Survival Time |
NA; NA | — |
| SECONDARY Prostate Cancer Specific Survival Time |
NA; NA | — |
| SECONDARY Non-irradiated Metastases Free Survival Time |
NA; NA | — |
| SECONDARY The Proportion of Patients With Complete PSA Response |
67; 40 | — |
| SECONDARY The Proportion of Patients With a PSA Partial Response 50 (PR50) |
89; 60 | — |
| SECONDARY The Proportion of Patients With a PSA Partial Response 90 (PR90) |
44; 60 | — |
| SECONDARY The Proportion of Patients That Respond to Treatment |
22; 20 | — |
| SECONDARY Patient-reported Outcome Based on NCCN-FACT FPSI-17 (Version 2) |
41.5; 39.1; 41.8; 39.7 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03556904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.