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

NCT04264208 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB-51987PROS0098NCI-2020-027791R01CA230438
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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)

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI

EXPERIMENTAL

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)

Drug: 68-Ga RM2.; Drug: 68-Ga PSMA11; Device: PET/MRI

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

EXPERIMENTAL

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)

Drug: 68-Ga RM2.; Drug: 68-Ga PSMA11; Device: PET/MRI

Interventions

68-Ga RM2. DRUG

PET radiopharmaceutical

Also known as: BAY86 7548, 68Ga DOTA Bombesin

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

68-Ga PSMA11 DRUG

PET radiopharmaceutical

Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound

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

PET/MRI DEVICE

PET/MR scanner by GE healthcare

Also known as: PET/MR scanner

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Andrei Iagaru: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Cancer Center

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BAY 86-7548; gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Early termination led to a small number of subjects analyzed

Results Point of Contact

• Title: Andrei Iagaru, MD
• Organization: Stanford University

aiagaru@stanford.edu

(650) 725-4711

Study Officials

• Andrei H Iagaru, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology (Nuclear Medicine)

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 11, 2020
• Study Start: February 5, 2020
• Primary Completion: November 22, 2022
• Study Completion: December 14, 2022
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)