68 Ga-PSMA for High Risk Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-02-26
• Target enrollment: 0
• Participant gender: Male

Summary

This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Edetic Acid; Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Male aged 21 years or older

• Ability to understand and provide written informed consent

• All patients must have histopathological proven adenocarcinoma of the prostate

• ECOG performance status 0-1

• No evidence of other malignancy (except squamous or basal cell skin cancers)

• Consent to use acceptable form of birth control following the imaging period (condoms for a period of seven days after injection if sexually active)

A. Inclusion criteria specific for the pre-prostatectomy group:

Untreated prostate Cancer with high-risk features, as defined as having at least one of the following criteria:

i. PSA ≥ 20.0 ng/mL ii. ISUP Gleason Grade Group 3, 4 or 5 iii. Clinical stage T3

B. Inclusion criteria specific for biochemical recurrence:

(i) Histopathological proven prostate adenocarcinoma (ii)Rising PSA after definitive therapy with prostatectomy or radiation (therapy (external beam or brachytherapy).

1. Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP.

2. Post-radiation therapy, PSA that is equal to or greater than 2 ng/ml rise above PSA nadir

Exclusion Criteria:

• Unable to tolerate a PET/CT (e.g. unable to lie flat)

• Recent history of a secondary malignancy in the past year, excluding non-melanoma skin cancer (non-metastatic)

• Known allergic reactions to 68-Ga, or gadolinium-based contrast agents.

• Treatment with another investigational drug or other intervention 2 years.

• Patient has any medical, psychological or social condition that, in opinion of the investigator will make difficult for the participant to tolerate study intervention.