Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study

Phase 3

Recruiting

• Conditions: ocalized Prostate Cancer; Localized Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12614000783628
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1.Male patients pathologically diagnosed with localized prostate cancer, awaiting prostatectomy
2. The time interval between last prostate biopsy and planned MP-MRI or planned 68Ga- HBED-CC PET must be not less than 8 weeks
3. No known problems with peripheral intravenous or central line access
4. Able to provide informed signed consent

Exclusion Criteria

1. Age under 18 years
2. Prior pelvic external beam radiation therapy or brachytherapy, prior chemotherapy, prior hormonal or radiation therapy for prostate cancer
3. Administered a radioisotope within 5 physical half-lives prior to study enrolment
4. Treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
5. Hemorrhagic cystitis or active prostatitis
6. Unable to lie flat during or unable to tolerate MP MRI or PET
7. Prior history of any other malignancy within last 2 years
8. Contraindication to MRI or MRI contrast agent or PET scan or [68Ga]gallium-labelled PSMA ligand
9. Claustrophobia not manageable by oral sedatives ie Temazepam
10. Moderate to severe rectal inflammation
11. Previous rectal surgery that will affect prostate imaging
12. MRI incompatible pacemakers
13. Metallic implants or pumps which are MRI incompatible
14. Renal impairment or hemodialysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of local prostate cancer foci by PET/CT scan and multi-parametric MRI[Outcome will be assessed once. After the imaging studies have been performed, and the final specimen retrieved, final analysis will be performed to correlate the results. There is no specific point time for the primary outcome. ]

Secondary Outcome Measures

Name	Time	Method
Correlation of the intensity of 68Ga-HBED-CC uptake with histopathologic Gleason Grade, tumour volume and tumour grade[Outcome will be assessed once. After the imaging studies have been performed, and the final specimen retrieved, final analysis will be performed to correlate the results. There is no specific point time for the outcome. ]