68 Ga-PSMA for High Risk Prostate Cancer

NCT04614363 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Pro00026240
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; High Risk

Keywords

PSMA; 68 Ga

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients With Lymph Node Involvement

  Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT.

  18 months

• Proportion of Patients Which Clinical Management Was Altered

  Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.

  18 months

Secondary Outcomes (2)

• Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness

  18 months

• Number of Patients With Suspicious Lesions

  18 months

Study Arms (1)

68 Ga PSMA

EXPERIMENTAL

Comparison between the results of 68 Ga-PSMA PET/CT to conventional imaging (bone scan, CT) in men with high risk prostate cancer.

Drug: 68Ga-PSMA

Interventions

68Ga-PSMA DRUG

All subjects enrolled in the study will receive a single IV dose of 3-7 mCi of 68 Ga-PSMA (study drug) followed by PET/CT imaging for detection of tumor location.

Also known as: 68 Ga-PSMA 11

68 Ga PSMA

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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

Results Point of Contact

• Title: Dr. Brian Miles
• Organization: Houston Methodist

bjmiles@houstonmethodist.org

713-441-8113

Study Officials

• Brian Miles, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: To minimize bias, all PET/CT images will be interpreted by a board certified radiologist. They will be blinded to the final outcome, such as histopathology of any biopsies and the outcome of subsequent imaging.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects will receive the Investigational Product.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 4, 2020
• Study Start: October 13, 2020
• Primary Completion: February 26, 2022
• Study Completion: April 25, 2023
• Last Updated: August 28, 2023
• Results First Posted: December 29, 2022

Record last verified: 2023-04

Locations

US (1)