Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

NCT03698370 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 3 other identifiers: IRB-46258NCI-2018-01799PROS0089
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

Conditions

Prostate Adenocarcinoma; PSA Progression; Recurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Lesions Detected by Investigational Imaging Agent

  The number of lesions detected on Ga- NeoBOMB1 positron emission tomography (PET)/magnetic resonance imaging (MRI), Ga PSMA R2 PET/MRI, and conventional MR will be compared.

  Up to approximately 2 hours to complete each scan

Secondary Outcomes (1)

• Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method

  At 1 year post-scan follow-up

Study Arms (2)

Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2

EXPERIMENTAL

Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.

Drug: Gallium Ga 68 DOTA-NeoBOMB1; Device: Gallium Ga 68 PSMA-R2

Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)

EXPERIMENTAL

Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.

Drug: Gallium Ga 68 DOTA-NeoBOMB1; Device: Gallium Ga 68 PSMA-R2

Interventions

Gallium Ga 68 DOTA-NeoBOMB1 DRUG

Administered intravenously (IV)

Also known as: Ga68-NeoBOMB1

Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2; Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)

Gallium Ga 68 PSMA-R2 DEVICE

Administered intravenously (IV)

Also known as: Ga68 PSMA-R2

Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2; Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)

Eligibility Criteria

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

You may qualify if:

• Biopsy proven prostate adenocarcinoma.
• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
• a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation.
• (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.
• (ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).
• b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.
• (i) A rise of PSA measurement of 2 or more ng/mL over the nadir.
• Able to provide written consent.
• Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent).

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.
• Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
• Metallic implants (contraindicated for magnetic resonance imaging \[MRI\]).

Sponsors & Collaborators

• Andrei Iagaru: lead

Study Sites (1)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

aiagaru@stanford.edu

650-728-4711

Study Officials

• Andrei Iagaru

  Stanford Cancer Institute Palo Alto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: December 15, 2020
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)