Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

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 ngdL) 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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT03556904

Recruitment Status:

Active, not recruiting

Sponsor:

University of Michigan Rogel Cancer Center

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There are 2 Locations for this study

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VA Ann Arbor Healthcare System
Ann Arbor Michigan, 48105, United States
University of Michigan Cancer Center
Ann Arbor Michigan, 48109, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT03556904

Recruitment Status:

Active, not recruiting

Sponsor:


University of Michigan Rogel Cancer Center

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