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

NCT03556904 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: UMCC 2017.163HUM00138918
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Median Duration of Response

  Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. A patient's designated response at any one time is a combination of the assessment of target lesions, non-target lesions, bone lesions and disease symptoms. Progression in this measure is defined as worsened pain or new sites of disease on imaging. Progression by pain due to prostate cancer requires evidence of disease at the site of pain and one or more palliative intervention (opioid therapy for 10 out of 14 consecutive days, radionuclide therapy or radiation therapy). Response and progression definitions used will be a combination of the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1 and the Prostate Cancer Working Group 3.

  At 12 Months

Secondary Outcomes (11)

• Median Objective Progression Free Survival (PFS) Time

  At 24 months

• Median Prostate Specific Antigen (PSA) PFS

  At 24 months

• Median Radiographic PFS

  At 24 months

• Overall Survival Time

  24 months

• Prostate Cancer Specific Survival Time

  24 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Drug: Hormone therapy or chemotherapy

Standard of Care + Ablative Radiation

EXPERIMENTAL

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.

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

Interventions

Ablative Radiation Therapy RADIATION

Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions.

Standard of Care + Ablative Radiation

Hormone therapy or chemotherapy DRUG

Current standard of care dosing with standard agents; hormone therapy or chemotherapy.

Also known as: enzalutamide, abiraterone, docetaxel, cabazitaxel

Standard of Care; Standard of Care + Ablative Radiation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Drug Therapy; enzalutamide; abiraterone; Docetaxel; cabazitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Zachery Reichert, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: June 14, 2018
• Study Start: December 10, 2018
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Locations

US (2)