Genomics in Michigan Impacting Observation or Radiation

Not Applicable

Active, not recruiting

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
GC (Decipher) Arm	Decipher Prostate Cancer Classifier	If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)	within 18 months of radical prostatectomy	Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.

Secondary Outcome Measures

Name	Time	Method
Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)	Up to 24 months post radical prostatectomy	Composite Expanded Prostate Cancer Index Composite (EPIC)-26 domain scores for a) urinary irritative function, b) urinary incontinence, and c) sexual function will be measured at baseline and 24 months post-radical prostatectomy. Each of the 3 domains is scaled from 0-100 (higher is better).
Time (From Randomization) to Adjuvant Treatment Administration	Up to 18 months post randomization	Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.
Time (From Randomization) to Salvage Treatment Administration	Up to 5 years post randomization	Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or \>18 months after surgery in the absence of documented BCR
Time (From Randomization) to Biochemical Recurrence (BCR)	Up to 5 years post randomization	BCR is defined as PSA ≥ 0.2 ng/ml.
Time (From Randomization) to Metastatic Disease (Regional or Distant)	Up to 5 years post randomization	Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan

Locations (13): Michigan Urological Clinic
🇺🇸
Grand Rapids, Michigan, United States
Urology Surgeons, PC
🇺🇸
Grand Rapids, Michigan, United States
University of Michigan Hospital and Health Systems
🇺🇸
Ann Arbor, Michigan, United States
Urologic Consultants
🇺🇸
Grand Rapids, Michigan, United States
Tri-City Urology
🇺🇸
Saginaw, Michigan, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Comprehensive Medical Center, PLLC
🇺🇸
Royal Oak, Michigan, United States
Spectrum Health Medical Group- Urology
🇺🇸
Grand Rapids, Michigan, United States
Urology Associates of Grand Rapids
🇺🇸
Grand Rapids, Michigan, United States
Bay Area Urology Associates, PC
🇺🇸
Traverse City, Michigan, United States
IHA Urology at St. Joe's Ann Arbor
🇺🇸
Ypsilanti, Michigan, United States
Michigan Institute of Urology-Town Center
🇺🇸
Troy, Michigan, United States