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

University of Michigan Rogel Cancer Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Ablative Radiation TherapyRADIATION

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.

Hormone therapy or chemotherapyDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: At 12 Months

Secondary Outcomes

Median Objective Progression Free Survival (PFS) Time

PFS is defined as the duration of time from start of treatment to date of progression or death (whichever is first). Initiation of other prostate directed therapies (excluding bisphosphonates or RANKL inhibitors) is considered to be progression. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Time frame: At 24 months

Median Prostate Specific Antigen (PSA) PFS

The Median PSA PFS is defined as the median duration of time from start of treatment to date that PSA progression is documented or death occurs (whichever is first). PSA progression is defined as a 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 2 ng/ml. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Time frame: At 24 months

Median Radiographic PFS

Radiographic PFS is defined as the duration of time from start of treatment to date that progression is radio-graphically documented or death occurs (whichever is first). Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Data from ClinicalTrials.gov

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