Trial Outcomes & Findings for Genomics in Michigan Impacting Observation or Radiation (NCT NCT02783950)

Last Updated: 2024-09-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

356 participants

Primary outcome timeframe

within 18 months of radical prostatectomy

Results posted on

2024-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	GC (Decipher) Arm 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.	Usual-Care-Based (UC) Arm If enrolled during the UC period, only the CAPRA-S results will be provided.
Overall Study STARTED	182	174
Overall Study COMPLETED	175	165
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genomics in Michigan Impacting Observation or Radiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GC (Decipher) Arm n=182 Participants 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.	Usual-Care-Based (UC) Arm n=174 Participants If enrolled during the UC period, only the CAPRA-S results will be provided.	Total n=356 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 6.5 • n=5 Participants	64.6 years STANDARD_DEVIATION 6.3 • n=7 Participants	64.7 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	182 Participants n=5 Participants	174 Participants n=7 Participants	356 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=5 Participants	147 Participants n=7 Participants	296 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	140 Participants n=5 Participants	140 Participants n=7 Participants	280 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Prostate Specific Antigen	6.6 ng/ML n=5 Participants	6.0 ng/ML n=7 Participants	6.4 ng/ML n=5 Participants

PRIMARY outcome

Timeframe: within 18 months of radical prostatectomy

Population: Includes all patients who were followed for at least 18 months or had an event prior to 18 months

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

Outcome measures

Outcome measures
Measure	GC (Decipher) Arm n=175 Participants 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.	Usual-Care-Based (UC) Arm n=165 Participants If enrolled during the UC period, only the CAPRA-S results will be provided.
Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)	19 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 18 months post randomization

Population: Population includes patients who had adjuvant treatment

Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.

Outcome measures

Outcome measures
Measure	GC (Decipher) Arm n=19 Participants 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.	Usual-Care-Based (UC) Arm n=12 Participants If enrolled during the UC period, only the CAPRA-S results will be provided.
Time (From Randomization) to Adjuvant Treatment Administration	259 days Interval 169.0 to 474.0	233.5 days Interval 65.0 to 501.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post randomization

BCR is defined as PSA ≥ 0.2 ng/ml.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post randomization

Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

GC (Decipher) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Usual-Care-Based (UC) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Todd Morgan, MD

University of Michigan

Phone: 734-647-8902

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place