Clinical trial NCT03556904: FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)
Official title: FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE): A Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Median duration of response
timeFrame: At 12 and at 18 Months
Secondary outcomes:
measure: Median objective progression free survival (PFS) time
timeFrame: At 12 and at 24 months
measure: Median prostate specific antigen (PSA) PFS
timeFrame: At 12 and at 24 months
measure: Median radiographic PFS
timeFrame: At 12 and at 24 months
measure: Overall survival time
timeFrame: At 12 and at 24 months
measure: Prostate cancer specific survival time
timeFrame: At 12 and at 24 months
measure: Non-irradiated metastases free survival time
timeFrame: At 12 and at 24 months
measure: The proportion of patients with complete PSA response
timeFrame: 24 months
measure: The proportion of patients with a PSA Partial Response 50 (PR50)
timeFrame: 24 months
measure: The proportion of patients with a PSA Partial Response 90 (PR90)
timeFrame: 24 months
measure: The proportion of patients that respond to treatment
timeFrame: 24 months
measure: Patient-reported outcome based on NCCN-FACT FPSI-17 (version 2)
timeFrame: 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Zachery Reichert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: