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

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

Condition: Prostate Cancer

Intervention:

  • Radiation: Radiation Therapy
  • Drug: Enzalutamide
  • Drug: Abiraterone
  • Drug: Docetaxel

Purpose: This clinical trial will determine whether the addition of radiotherapy to standard of care first line systemic therapy improves objective progression-free survival rate (combined radiographic and clinical) at 18 months, compared to first line systemic therapy alone.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03556904

Sponsor: University of Michigan Rogel Cancer Center

Primary Outcome Measures:

  • Measure: The proportion of patients who are progression-free and alive at 18 months
  • Time Frame: 18 Months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Median objective progression free survival time
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Median PSA progression free survival time
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: Median radiographic progression free survival
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Overall survival time
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Prostate cancer specific survival time
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Non-irradiated metastases free survival time
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: The proportion of patients with complete PSA response
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: The proportion of patients with a PSA Partial Response 50 (PR50)
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: The proportion of patients with a PSA Partial Response 90 (PR90)
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: The proportion of patients that respond to treatment
  • Time Frame: 24 months
  • Safety Issue:

Estimated Enrollment: 72

Study Start Date: August 14, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Subjects must have biopsy-confirmed adenocarcinoma of the prostate
  • Patients must discontinue all systemic or experimental therapies for at least 2 weeks prior to registration with no evidence of a falling PSA (prostate specific antigen) after washout. LHRH (luteinizing hormone-releasing hormone) analogues must be continued if they have not undergone orchiectomy.
  • 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 first line 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 unless disease free for a minimum of 2 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.

Exclusion Criteria:

  • Planned first line systemic therapy with Radium-223 dichloride or sipuleucel-T
  • 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

Contact:

  • Zachery Reichert, MD, PhD
  • (734)-764-3066

Location:

  • University of Michigan Cancer Center
  • Ann Arbor Michigan 48109 United States

View trial on ClinicalTrials.gov

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