Prostate Cancer Clinical Trial

Genomics in Michigan Impacting Observation or Radiation

Summary

To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.

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Full Description

This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.

The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.

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Eligibility Criteria

Inclusion Criteria:

Prostate cancer patients who have undergone radical prostatectomy
PSA < 0.1 ng/ml at enrollment

At least one of the following:

pT3 (seminal vesicle invasion or extraprostatic extension), or
Positive surgical margins
Radical prostatectomy within one year of enrollment

Exclusion Criteria:

Individuals who have any of the following will not be eligible to participate:

Have regional or distant metastatic disease
Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
Node positive

Study is for people with:

Prostate Cancer

Estimated Enrollment:

356

Study ID:

NCT02783950

Recruitment Status:

Active, not recruiting

Sponsor:

University of Michigan Rogel Cancer Center

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

356

Study ID:

NCT02783950

Recruitment Status:

Active, not recruiting

Sponsor:


University of Michigan Rogel Cancer Center

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