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FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03556904•University of Michigan Rogel Cancer Center

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

Age

18 - No limit years

Sex

MALE

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)
+3 more criteria

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

Locations (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

December 10, 2018

Primary Completion Date

July 28, 2023

Completion Date

July 28, 2023

Last Updated

January 15, 2026

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Ablative Radiation Therapy

RADIATION

Hormone therapy or chemotherapy

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC