Phase 2 N=80 Diagnostic

68 Ga-PSMA for High Risk Prostate Cancer

Prostate Cancer · High Risk

Bottom Line

View on ClinicalTrials.gov: NCT04614363 ↗

Enrolled (actual)

Serious AEs

3.8%

Results posted

Dec 2022

Primary outcome: Primary: Proportion of Patients With Lymph Node Involvement — 4; 28 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 68Ga-PSMA (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: Male
Sponsor: The Methodist Hospital Research Institute
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With Lymph Node Involvement	4; 28	—
PRIMARY Proportion of Patients Which Clinical Management Was Altered	2; 30	—
SECONDARY Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness	22.45; 0; 43.8; 16.9	—
SECONDARY Number of Patients With Suspicious Lesions	4; 17	—

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.

Eligibility 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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04614363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.