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

Institute of Cancer Research, United Kingdom

Status: Enrolling

Conditions: Mismatch Repair Gene Mutation; BRCA Mutation; PALB2 Gene Mutation; HOXB13 Germline Mutation; CHEK2 Gene Mutation; ATM Gene Mutation; Prostate Cancer

Treatments: Other: MRI pelvis or CT imaging under clinical management for Pr Ca; Other: PET-CT imaging; Other: Whole body bone scan imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05097274

CCR4131

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 1 patient group

DNA repair gene mutation carriers

Description:

* 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

Treatment:

Other: Whole body bone scan imaging

Other: PET-CT imaging

Other: MRI pelvis or CT imaging under clinical management for Pr Ca