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

Prostate Cancer Clinical Trial

Official title:

Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04176497
• Other study ID #: LCCC1908
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 16, 2020
• Est. completion date: February 7, 2028

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: February 7, 2028
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68Ga-HBED-CC-PSMA
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity after Radiation	Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets	End of treatment to 1 year post-treatment
Secondary	Adverse Events	Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer.	Baseline to 5 years post-treatment
Secondary	Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition	Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.	Baseline to 5 years post-treatment
Secondary	Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)	Measuring patient-reported quality of life using EPIC-26 and PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy target volumes.	Baseline to 5 years post-treatment
Secondary	Screened Subjects	Measuring the proportion of screen subjects who are enrolled on the study	Through study completion, average of 2 years
Secondary	The feasibility of meeting dose constraints	The feasibility of meeting dose constraints will be defined as the proportion of subjects' radiotherapy treatment plan meets dose constraint criteria for PTV max, CTV, DIL, rectum, bladder, urethra, bowel, and penile bulb, as defined in the protocol.	Baseline
Secondary	Performance of PSMA-PET/MRI to PSMA PET/CT	Performance of PSMA-PET/MRI to PSMA PET/CT will be defined as rate of identification and delineation (e.g. sensitivity and specificity) of dominant intra-prostatic lesion in comparison to a gold standard of image-guided prostate biopsy.	Baseline
Secondary	Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis	Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis will be defined using PSMA-PET/MRI to PSMA PET/CT images	Baseline

External Links

•   UNC Lineberger Comprehensive Cancer Center