HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET, 68Ga-PSMA-11 PET and Multi Parametric MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04264208
• Other study ID #: IRB-51987
• Secondary ID: PROS0098NCI-2020
• Status: Terminated
• Phase: Phase 2
• Start date: February 5, 2020
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)

Description:

Primary Objective: 1. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. 2. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 14, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18 years of age;
• Patients must be able to provide informed consent;
• Histologically proven low-grade or intermediate-grade prostate cancer (PC)
• Scheduled to undergo targeted local therapy (HDR brachytherapy).

Exclusion Criteria:

• Inability to lie still for the entire imaging time;
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance;
• Metallic implants (contraindicated for MRI).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68-Ga RM2.
PET radiopharmaceutical
• 68-Ga PSMA11
PET radiopharmaceutical

Device:
• PET/MRI
PET/MR scanner by GE healthcare

Locations

Country	Name	City	State
United States	Stanford Cancer Center	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Andrei Iagaru	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Assessment of PET Based PC Lesions	Assessment of whether 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. Detection of PC lesions will be assessed by 68Ga PSMA11 and 68Ga RM2 PET scans.	Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Primary	Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained	Assessment of whether 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment. Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Primary	Progression Free Survival (PFS)	Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.	24 months