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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: 68Ga-HBED-CC-PSMA

Study type: Interventional

Funder types: Other

Identifiers

NCT04176497

LCCC1908

Details and patient eligibility

About

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.

Full description

PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.

Enrollment: 7 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

PMSA-PET/MRI

Experimental group

Description:

Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Treatment:

Drug: 68Ga-HBED-CC-PSMA