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

Prostate Cancer Clinical Trial

— GENPET  

Official title:

An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a BRCA Gene Mutation (GENPET)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097274
• Other study ID #: CCR4131
• Status: Recruiting
• Start date: October 15, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Institute of Cancer Research, United Kingdom
• Contact: Rosalind A Eeles, FRCP FRCR
• Phone: 44 208 661 3642
• Email: rosalind.eeles[@]icr.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 germline BRCA mutations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed pathogenic germline mutation in either BRCA1 or BRCA2
• 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)

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• MRI pelvis or CT imaging under clinical management for Pr Ca
Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images.
• Whole body bone scan imaging
bone scan of the whole body (under clinical diagnosis).
• PET-CT imaging
Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.

Locations

Country	Name	City	State
United Kingdom	Cancer Genetics Unit, Royal Marsden Hospital	London	Sutton, Surrey

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cancer Research UK, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer		Within 12 months of the last FCH-PET-CT scan
Other	To investigate the prognostic significance of FCH-PET-CT findings (e.g. employing standard SUV parameters and heterogeneity of PET texture of the primary prostate tumour)		Within 12 months of the last FCH-PET-CT scan
Other	To assess agreement between imaging readers in assessing FCH-PET-CT scans.		Within 12 months of the last FCH-PET-CT scan
Primary	1. Sensitivity of 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.	Within 12 months of the last FCH-PET-CT scan
Secondary	2. Outline the Specificity of the 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	Within 12 months of the last FCH-PET-CT scan
Secondary	3.Incidence and sites of additional metastases identified on FCH-PET-CT compared with combined MRI/bone scan.		Within 12 months of the last FCH-PET-CT scan
Secondary	4.To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making		Within 12 months of the last FCH-PET-CT scan