Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery (PRO-IMPACT)

GenomeDx Biosciences

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Decipher

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02080689

CU 004

Details and patient eligibility

About

The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

Full description

This prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing Decipher results for eligible patient cases. The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-RP:

1. In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
2. In the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)

A total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. The study as a whole will enroll 300 patient cases.

As a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.

Enrollment: 286 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathological T3 stage of disease (i.e., EPE or SVI), or
2. Positive surgical margins, or
3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Exclusion criteria

1. For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
2. For salvage setting patients: Metastatic Disease at PSA rise
3. Failure of PSA to nadir after surgery
4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
5. Received any adjuvant chemotherapy
6. Required patient clinical data is not available for evaluation of eligibility criteria
7. For adjuvant setting patients, any treatment received after surgery
8. For salvage setting patients, lack of documented treatment or management recommendation on file
9. Tissue specimen is inadequate for sampling and analysis

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

Salvage setting

Other group

Description:

The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria in the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)

Treatment:

Other: Decipher

Adjuvant setting

Other group

Description:

The clinical utility of Decipher will be evaluated for patients in the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)

Treatment:

Other: Decipher