Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

March 11, 2022 updated by: Jeanne Link

68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of potential metastatic or recurrent disease.

OUTLINE:

Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7 mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100 minutes. Following the PET scan with the study agent, participants will undergo either surgical management or treatment for metastatic disease in accordance with institutional standards.

Patients will be observed for 2 hours after injection of the radiotracer, and will be followed-up 1-3 days post injection with a phone call.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Knight Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

PLANNED PROSTATECTOMY

  • Biopsy-proven prostate adenocarcinoma
  • Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater.
  • Planned prostatectomy with lymph node dissection
  • Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)

BIOCHEMICAL RECURRENCE

  • Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical recurrence).
  • If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence).
  • No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).

ALL

  • Karnofsky performance status (KPS) >= 50 (ECOG/WHO 0, 1, or 2)
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
  • Ability to understand and the willingness to provide informed consent

Exclusion Criteria:

  • History of Stevens-Johnson syndrome
  • Known Paget's disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeanne Link

Collaborators

Oregon Health and Science University
OHSU Knight Cancer Institute
OHSU Center of Radiochemistry Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00020072
  • STUDY00020073 (OHSU Knight Cancer Institute IRB Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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