PSMA-PET/CT imaging in the EArly detection of Cancer of the Prostate with High Risk Features

PSMA-PET/CT imaging in the EArly detection of Cancer of the Prostate with High Risk Features - PEACH trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50089

Enrollment

Registered

2019-06-28

Start date

2019-11-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignancy of the prostate Prostate Cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men * 45 years with no history of PCa and no prior prostate biopsies with suspected, potentially aggressive PCa due to an elevated PSA-level between 20 and 50 ng/mL are eligible.

Exclusion criteria

Exclusion criteria: - Previous diagnosis of prostate cancer - Previous prostate biopsy - Previous PSMA PET/CT scan

Design outcomes

Primary

Measure	Time frame
OUTCOME MEASURES. It is assessed: 1) the (reduced) number of prostate biopsy procedures in the 18F-PSMA-diagnostic pathway, 2) the (reduced) number of prostate biopsy cores taken, 3) the (increased) number of clinically significant (Gleason score 3 + 4 = 7, 4 + 3 = 7,8-10) prostate cancers detected per prostate biopsy session, 4) the calculated (reduced) number of complicated urinary tract infections such as urosepsis due to prostate biopsy.	—

Measure

Time frame

OUTCOME MEASURES. It is assessed: 1) the (reduced) number of prostate biopsy procedures in the 18F-PSMA-diagnostic pathway, 2) the (reduced) number of prostate biopsy cores taken, 3) the (increased) number of clinically significant (Gleason score 3 + 4 = 7, 4 + 3 = 7,8-10) prostate cancers detected per prostate biopsy session, 4) the calculated (reduced) number of complicated urinary tract infections such as urosepsis due to prostate biopsy.

—

Secondary

Measure	Time frame
ND	—

Countries

Netherlands

Outcome results