Clinical trial

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

Name

IRB-51987

Description

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)

Trial arms

Trial start

2020-02-05

Estimated PCD

2022-11-22

Trial end

2022-12-14

Status

Terminated

Phase

Early phase I

Treatment

68-Ga RM2.

PET radiopharmaceutical

Arms:

68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI, 68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI

Other names:

BAY86 7548, 68Ga DOTA Bombesin

68-Ga PSMA11

PET radiopharmaceutical

Arms:

68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI, 68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI

Other names:

DFKZ 11, HBED CC PSMA, Heidelberg compound

PET/MRI

PET/MR scanner by GE healthcare

Arms:

68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI, 68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI

Other names:

PET/MR scanner

Size

Primary endpoint

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

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

Progression Free Survival (PFS)

24 months

Eligibility criteria

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

Updated at

2024-02-01

1 organization

2 products

1 indication

Organization

Product

Indication

Product