Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

NCT05415228 | Unknown

• 1 other identifier: HUM00198146
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11). The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.

Conditions

Prostate Adenocarcinoma

Keywords

Prostate Cancer

Interventions

68Ga-PSMA-11 DRUG

68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging

Also known as: HBED-CC, Glu-urea-Lys(Ahx)-HBED-CC, PSMA-HBED-CC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological proven prostate adenocarcinoma
• Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL
• Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA
• Ability to understand a written informed consent document and the willingness to sign it

You may not qualify if:

• Current investigational therapy for prostate cancer
• Unable to lie flat, still, or tolerate a PET/CT scan

Sponsors & Collaborators

• Morand Piert, MD: lead

Related Publications (1)

• Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29.

  PMID: 34326126 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; N,N'-bis(2-hydroxy-5-(ethylene-beta-carboxy)benzyl)ethylenediamine N,N'-diacetic acid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 13, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05