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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04854369
Expanded Access Status : No longer available
First Posted : April 22, 2021
Last Update Posted : April 11, 2023
Information provided by (Responsible Party):
Tulane University

Brief Summary:

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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Drug: 68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: 68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Drug: 68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit
    The PSMA-11 Sterile Cold Kit is supplied as a kit for preparation of radiolabeled Gallium-68 PSMA-11 Injection, with 3 configurations (A, B or D) to accommodate the specificities of the 68Ge/68Ga generator that is used.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04854369

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United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University
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Principal Investigator: Alton O Sartor, MD Tulane University

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Responsible Party: Tulane University Identifier: NCT04854369    
Other Study ID Numbers: 2021-583
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023
Keywords provided by Tulane University:
68 Ga-PSMA-11
Prostate cancer
Metastatic prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Gallium 68 PSMA-11
Molecular Mechanisms of Pharmacological Action