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

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: 68-Ga RM2.; Drug: 68-Ga PSMA11; Device: PET/MRI

• Registration Number: NCT04264208
• Lead Sponsor: Andrei Iagaru

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-04
• Study Start: 2020-02-05
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Primary Completion: 2022-11-22
• Study Completion: 2022-12-14
• Results First Submitted: 2023-11-07
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Results First Posted: 2024-02-01
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 4

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI	68-Ga RM2.	Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI	68-Ga PSMA11	Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI	PET/MRI	Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI	68-Ga RM2.	Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI	68-Ga PSMA11	Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI	PET/MRI	Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	24 months	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.
Number of Participants With Successful Assessment of PET Based PC Lesions	Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment	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.
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained	Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment	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.

Trial Locations

Locations (1)

Stanford Cancer Center; 🇺🇸 Stanford, California, United States