Clinical trial · Interventional
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE): A Phase II Randomized Trial
NCT03556904CI-TRIAL-00100932completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablative Radiation Therapy | Radiation | — | UNRESOLVED |
| Hormone therapy or chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- 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.
- interventionNames
- Drug: Hormone therapy or chemotherapy
- type
- EXPERIMENTAL
- label
- Standard of Care + Ablative Radiation
- 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.
- interventionNames
- Radiation: Ablative Radiation Therapy
- Drug: Hormone therapy or chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.