PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Edetic Acid

Criteria

Inclusion Criteria:

• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.

• Histologically confirmed prostate adenocarcinoma

• Unfavorable intermediate or high-risk, based on the NCCN criteria28 (Appendix A.1), with appropriate staging (e.g. bone scan).

• Subject has adequate performance status as defined by ECOG performance status of 0-2.

• Subject is willing and able to comply with the protocol as determined by the Treating Investigator.

• Subject speaks English (quality of life instrument is validated in English).

Exclusion Criteria:

• Contraindications for MRI

• Other prior or concomitant malignancies with the exception of:

• Non-melanoma skin cancer

• Other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence.

• Inflammatory bowel disease

• Absolute contraindications to brachytherapy per American Brachytherapy Society:

unacceptable operative risk, absence of rectum, large TURP defects