The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.

Recruiting

• Conditions: Mismatch Repair Gene Mutation; HOXB13 Germline Mutation; BRCA Mutation; ATM Gene Mutation; PALB2 Gene Mutation; Prostate Cancer; CHEK2 Gene Mutation
• Interventions: Other: MRI pelvis or CT imaging under clinical management for Pr Ca; Other: Whole body bone scan imaging; Other: PET-CT imaging

• Registration Number: NCT05097274
• Lead Sponsor: Institute of Cancer Research, United Kingdom

Brief Summary

The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI/CT of the abdomen \& pelvis in detecting the increased incidence of metastasis (nodal/distant outside the pelvis) in men with prostatic carcinoma with mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-15
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM.

• Over the age of 18

• Diagnosed with prostate cancer and at a time when staging imaging is clinically indicated; either:

  • At a new diagnosis
  • Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy
  • Patients on active surveillance with a PSA doubling time of 6 months or less

Exclusion Criteria

• Diagnosis of other malignancy (excluding basal cell cancer/squamous cell cancer of the skin) within five years of diagnosis
• Known metastatic prostate cancer, both local and distant
• Patients who have received any oncological treatment within the last six months
• Patients on any investigational drug treatment
• Patients on steroids
• Known history of inflammatory/infective diseases (e.g. sarcoidosis, tuberculosis, inflammatory bowel disease)
• Contraindications to having an MRI using the standard MRI checklist (e.g. pacemakers, aneurysm clips, claustrophobia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DNA repair gene mutation carriers	MRI pelvis or CT imaging under clinical management for Pr Ca	* Newly diagnosed with prostate cancer (any Gleason score, any stage, any PSA) * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy * Patients on active surveillance, with a PSA doubling time of 6 months or less
DNA repair gene mutation carriers	PET-CT imaging	* Newly diagnosed with prostate cancer (any Gleason score, any stage, any PSA) * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy * Patients on active surveillance, with a PSA doubling time of 6 months or less
DNA repair gene mutation carriers	Whole body bone scan imaging	* Newly diagnosed with prostate cancer (any Gleason score, any stage, any PSA) * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy * Patients on active surveillance, with a PSA doubling time of 6 months or less

Primary Outcome Measures

Name	Time	Method
1. Sensitivity of FCH-PET-CT scan	Within 12 months of the last FCH-PET-CT scan	To determine if the sensitivity of FCH-PET-CT is superior to combined conventional imaging (MRI (T2 and T1 weighted)/CT and bone scan) in detecting nodal and distant (outside the pelvis) metastases in BRCA1/2 germline mutation carriers with prostate cancer.

Secondary Outcome Measures

Name	Time	Method
Impact of FCH-PET-CT findings	Within 12 months of the last FCH-PET-CT scan	To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making
2. Outline the Specificity of the FCH-PET-CT scan	Within 12 months of the last FCH-PET-CT scan	determining the positive predictive value (PPV) and negative predictive value (NPV) in detecting metastatic disease in BRCA mutation carriers with prostate cancer
Metastasis Incidence	Within 12 months of the last FCH-PET-CT scan	3.Incidence and sites of additional metastases identified on FCH-PET-CT compared with combined MRI/bone scan.

Trial Locations

Locations (1)

Cancer Genetics Unit, Royal Marsden Hospital; 🇬🇧 London, Sutton, Surrey, United Kingdom