68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly) (Firefly)

April 9, 2023 updated by: Tulane University

68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer

This is a prospective, Phase 2, single-center, open-label study of 68Ga-PSMA-11 PET scans in patients with biochemically recurrent prostate cancer or those diagnosed and untreated with high risk or very high risk localized prostate cancer, or oligometastatic (defined as three or fewer metastatic lesions on conventional imaging) prostate cancer (using NCCN classification for localized disease).

Approximately 300 patients are planned for enrollment in this study, divided into two cohorts. Cohort A will be 225 patients in the recurrent setting. Cohort B will be 75 patients in the up-front newly diagnosed setting.

After a screening period (6-week window), eligible patients will undergo baseline assessments as per the Schedule of Study Activities. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population
  • Treatment IND/Protocol

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
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center

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

Description

Inclusion Criteria:

  • Males greater than 18 years of age.
  • Histologically proven adenocarcinoma of the prostate. Diagnosis must be stated in a pathology report and confirmed by the investigator.
  • Patients must meet the criteria of one of the following cohorts:

Cohort A: (n=225) Biochemical recurrence; defined as any of the following:

  • PSA ≥ 0.2 ng/mL and rising in at least two consecutive tests (at least one week apart) within 6 months of date of consent for patients treated with radical prostatectomy.
  • PSA >2.0 ng/mL above the nadir and rising post-radiation (external beam or brachytherapy) +/- hormones, in at least 2 consecutive tests (at least one week apart) within 6 months of consent
  • In patients with no prior definitive surgery or radiation, PSA ≥ 2 ng/mL greater than the post therapy nadir after androgen deprivation therapy.

Note: Patients whom have had more than one prior therapy, should be defined recurrent by their most recent therapy type. For patients who have had any ADT, are mCRPC, shall fall into that category for allocation and eligibility.

Cohort B: (n=75) No prior treatment defined as one of the following:

o Patient has primary diagnosis of "high risk" or "very high risk" localized prostate cancer, or regional prostate cancer (TxN1M0) or oligometastatic cancer (TxNXM1) with less than three metastatic lesions by conventional imaging) and has not received prior treatment.

Note: high risk/very high risk is denoted by Gleason 8-10, or PSA >20, or clinical stage T3a/T4 disease (see NCCN guidelines v1.2020).

Patients in this cohort must be considered candidates for initial definitive therapy at the time of study enrollment.

  • Life expectancy of >6 months
  • Patients should have a Comprehensive Metabolic Panel, PSA, and Testosterone drawn within 4 weeks of imaging

Exclusion Criteria:

  • Claustrophobia or any other condition that would preclude PET/CT imaging.
  • Patients with known metastatic prostate cancer, with 4 or more lesions on conventional imaging

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

Tulane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 16, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-583

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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