Prostate Cancer
Conditions
Keywords
Genomics, Adjuvant Treatment
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.
Interventions
OTHERDecipher Prostate Cancer Classifier
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.
Sponsors
Michigan Urological Surgery Improvement Collaborative (MUSIC)
GenomeDx Biosciences Corp
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 182 |
| Usual-Care-Based (UC) Arm If enrolled during the UC period, only the CAPRA-S results will be provided. | 174 |
| Total | 356 |
Baseline characteristics
| Characteristic | GC (Decipher) Arm | Usual-Care-Based (UC) Arm | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 6.5 | 64.6 years STANDARD_DEVIATION 6.3 | 64.7 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 147 Participants | 296 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 31 Participants | 25 Participants | 56 Participants |
| Prostate Specific Antigen | 6.6 ng/ML | 6.0 ng/ML | 6.4 ng/ML |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 11 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 20 Participants | 42 Participants |
| Race (NIH/OMB) White | 140 Participants | 140 Participants | 280 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 182 Participants | 174 Participants | 356 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 182 | 0 / 174 |
| other Total, other adverse events | 0 / 182 | 0 / 174 |
| serious Total, serious adverse events | 0 / 182 | 0 / 174 |
Outcome results
Primary
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GC (Decipher) Arm | Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) | 19 Participants |
| Usual-Care-Based (UC) Arm | Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) | 12 Participants |
p-value: 0.27Chi-squared
Secondary
Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)
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 frame: Up to 24 months post radical prostatectomy
Secondary
Time (From Randomization) to Adjuvant Treatment Administration
Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.
Time frame: Up to 18 months post randomization
Population: Population includes patients who had adjuvant treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GC (Decipher) Arm | Time (From Randomization) to Adjuvant Treatment Administration | 259 days |
| Usual-Care-Based (UC) Arm | Time (From Randomization) to Adjuvant Treatment Administration | 233.5 days |
p-value: 0.7Wilcoxon Rank Test p-value
Secondary
Time (From Randomization) to Biochemical Recurrence (BCR)
BCR is defined as PSA ≥ 0.2 ng/ml.
Time frame: Up to 5 years post randomization
Secondary
Time (From Randomization) to Metastatic Disease (Regional or Distant)
Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan
Time frame: Up to 5 years post randomization
Secondary
Time (From Randomization) to Salvage Treatment Administration
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 frame: Up to 5 years post randomization