Genomics in Michigan Impacting Observation or Radiation

NCT02783950 | Completed Results

• 3 other identifiers: UMCC 2016.020CU 008HUM00110858
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 13

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.

Conditions

Prostate Cancer

Keywords

Genomics; Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)

  Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.

  within 18 months of radical prostatectomy

Secondary Outcomes (5)

• Time (From Randomization) to Adjuvant Treatment Administration

  Up to 18 months post randomization

• Time (From Randomization) to Salvage Treatment Administration

  Up to 5 years post randomization

• Time (From Randomization) to Biochemical Recurrence (BCR)

  Up to 5 years post randomization

• Time (From Randomization) to Metastatic Disease (Regional or Distant)

  Up to 5 years post randomization

• Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)

  Up to 24 months post radical prostatectomy

Study Arms (2)

GC (Decipher) Arm

OTHER

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.

Other: Decipher Prostate Cancer Classifier

Usual-Care-Based (UC) Arm

NO INTERVENTION

If enrolled during the UC period, only the CAPRA-S results will be provided.

Interventions

Decipher Prostate Cancer Classifier OTHER

The Decipher test (GenomeDx Biosciences, San Diego, CA) is a genomic test that predicts high grade disease, the probability of metastasis and prostate cancer-specific mortality for men with prostate cancer.

Also known as: Decipher Post-Op

GC (Decipher) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Michigan Urological Surgery Improvement Collaborative (MUSIC): collaborator
• GenomeDx Biosciences Corp: collaborator

Study Sites (13)

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Urologic Consultants

Grand Rapids, Michigan, 49503, United States

Location

Urology Associates of Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Michigan Urological Clinic

Grand Rapids, Michigan, 49546, United States

Location

Spectrum Health Medical Group- Urology

Grand Rapids, Michigan, 49546, United States

Location

Urology Surgeons, PC

Grand Rapids, Michigan, 49546, United States

Location

Comprehensive Medical Center, PLLC

Royal Oak, Michigan, 48073, United States

Location

Tri-City Urology

Saginaw, Michigan, 48601, United States

Location

Bay Area Urology Associates, PC

Traverse City, Michigan, 49684, United States

Location

Michigan Institute of Urology-Town Center

Troy, Michigan, 48084, United States

Location

IHA Urology at St. Joe's Ann Arbor

Ypsilanti, Michigan, 48197, United States

Location

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  PMID: 40934443 DERIVED

Related Links

• Website for MUSIC

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Todd Morgan, MD
• Organization: University of Michigan

tomorgan@med.umich.edu

734-647-8902

Study Officials

• Todd Morgan, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Michael Cher, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: January 17, 2017
• Primary Completion: February 1, 2020
• Study Completion: April 2, 2024
• Last Updated: September 26, 2024
• Results First Posted: February 25, 2021

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)