68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly) (Firefly)
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| ClinicalTrials.gov Identifier: NCT04854369 |
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Expanded Access Status :
No longer available
First Posted : April 22, 2021
Last Update Posted : April 11, 2023
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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 |
| 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 |
- 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.
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.
| 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
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 ClinicalTrials.gov identifier (NCT number): NCT04854369
| United States, Louisiana | |
| Tulane Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Principal Investigator: | Alton O Sartor, MD | Tulane University |
| Responsible Party: | Tulane University |
| ClinicalTrials.gov 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 |
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68 Ga-PSMA-11 Prostate cancer Metastatic prostate cancer |
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Prostatic Neoplasms 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 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |