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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-12-14

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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68Ga-RM2 PET MRI then 68 Ga PMSA11 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)

Group Type EXPERIMENTAL

68-Ga RM2.

Intervention Type DRUG

PET radiopharmaceutical

68-Ga PSMA11

Intervention Type DRUG

PET radiopharmaceutical

PET/MRI

Intervention Type DEVICE

PET/MR scanner by GE healthcare

68Ga-PSMA-11 PET MRI then 68Ga-RM2 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)

Group Type EXPERIMENTAL

68-Ga RM2.

Intervention Type DRUG

PET radiopharmaceutical

68-Ga PSMA11

Intervention Type DRUG

PET radiopharmaceutical

PET/MRI

Intervention Type DEVICE

PET/MR scanner by GE healthcare

Interventions

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68-Ga RM2.

PET radiopharmaceutical

Intervention Type DRUG

68-Ga PSMA11

PET radiopharmaceutical

Intervention Type DRUG

PET/MRI

PET/MR scanner by GE healthcare

Intervention Type DEVICE

Other Intervention Names

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BAY86 7548 68Ga DOTA Bombesin DFKZ 11 HBED CC PSMA Heidelberg compound PET/MR scanner

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No