Back to results68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly) (Firefly)
Primary Purpose
Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit
Sponsored by
About this trial
This is an expanded access trial for Prostatic Neoplasms focused on measuring 68 Ga-PSMA-11, Prostate cancer, Metastatic prostate cancer
Eligibility Criteria
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
Sites / Locations
- Tulane Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04854369
Brief Title
68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly)
Acronym
Firefly
Official Title
68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
Keywords
68 Ga-PSMA-11, Prostate cancer, Metastatic prostate cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit
Intervention Description
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alton O Sartor, MD
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20690197
Citation
Cooperberg MR, Vickers AJ, Broering JM, Carroll PR. Comparative risk-adjusted mortality outcomes after primary surgery, radiotherapy, or androgen-deprivation therapy for localized prostate cancer. Cancer. 2010 Nov 15;116(22):5226-34. doi: 10.1002/cncr.25456. Erratum In: Cancer. 2011 Jun 15;117(12):2825.
Results Reference
background
PubMed Identifier
26700655
Citation
Wallis CJD, Saskin R, Choo R, Herschorn S, Kodama RT, Satkunasivam R, Shah PS, Danjoux C, Nam RK. Surgery Versus Radiotherapy for Clinically-localized Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Jul;70(1):21-30. doi: 10.1016/j.eururo.2015.11.010. Epub 2015 Dec 15.
Results Reference
background
PubMed Identifier
11743287
Citation
Lau WK, Bergstralh EJ, Blute ML, Slezak JM, Zincke H. Radical prostatectomy for pathological Gleason 8 or greater prostate cancer: influence of concomitant pathological variables. J Urol. 2002 Jan;167(1):117-22. Erratum In: J Urol. 2004 Feb;171(2 Pt 1):811.
Results Reference
background
PubMed Identifier
23707439
Citation
Thompson IM, Valicenti RK, Albertsen P, Davis BJ, Goldenberg SL, Hahn C, Klein E, Michalski J, Roach M, Sartor O, Wolf JS Jr, Faraday MM. Adjuvant and salvage radiotherapy after prostatectomy: AUA/ASTRO Guideline. J Urol. 2013 Aug;190(2):441-9. doi: 10.1016/j.juro.2013.05.032. Epub 2013 May 21.
Results Reference
background
PubMed Identifier
19758614
Citation
Moreira DM, Presti JC Jr, Aronson WJ, Terris MK, Kane CJ, Amling CL, Freedland SJ. Natural history of persistently elevated prostate specific antigen after radical prostatectomy: results from the SEARCH database. J Urol. 2009 Nov;182(5):2250-5. doi: 10.1016/j.juro.2009.07.022. Epub 2009 Sep 16.
Results Reference
background
PubMed Identifier
17513807
Citation
Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, Forman JD, Zelefsky MJ, Kestin LL, Roehrborn CG, Catton CN, DeWeese TL, Liauw SL, Valicenti RK, Kuban DA, Pollack A. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007 May 20;25(15):2035-41. doi: 10.1200/JCO.2006.08.9607. Erratum In: J Clin Oncol. 2007 Sep 10;25(26):4153.
Results Reference
background
PubMed Identifier
29381466
Citation
Ajib K, Zanaty M, Alnazari M, Rajih E, Hueber PA, Mansour M, Valdivieso R, Negrean C, Karakiewicz PI, Taussky D, Delouya G, El-Hakim A, Zorn KC. Functional and oncological outcomes of salvage external beam radiotherapy following robot-assisted radical prostatectomy in a Canadian cohort. Can Urol Assoc J. 2018 Feb;12(2):45-49. doi: 10.5489/cuaj.4641. Epub 2017 Dec 1.
Results Reference
background
PubMed Identifier
25366677
Citation
Freedland SJ, Rumble RB, Finelli A, Chen RC, Slovin S, Stein MN, Mendelson DS, Wackett C, Sandler HM; American Society of Clinical Oncology. Adjuvant and salvage radiotherapy after prostatectomy: American Society of Clinical Oncology clinical practice guideline endorsement. J Clin Oncol. 2014 Dec 1;32(34):3892-8. doi: 10.1200/JCO.2014.58.8525. Epub 2014 Nov 3.
Results Reference
background
PubMed Identifier
30920593
Citation
Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.
Results Reference
background
PubMed Identifier
31375469
Citation
Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30. Erratum In: Lancet Oncol. 2019 Nov;20(11):e613. Lancet Oncol. 2020 Jun;21(6):e304.
Results Reference
background
PubMed Identifier
27363387
Citation
Perera M, Papa N, Christidis D, Wetherell D, Hofman MS, Murphy DG, Bolton D, Lawrentschuk N. Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Dec;70(6):926-937. doi: 10.1016/j.eururo.2016.06.021. Epub 2016 Jun 28.
Results Reference
background
PubMed Identifier
28283702
Citation
Fendler WP, Eiber M, Beheshti M, Bomanji J, Ceci F, Cho S, Giesel F, Haberkorn U, Hope TA, Kopka K, Krause BJ, Mottaghy FM, Schoder H, Sunderland J, Wan S, Wester HJ, Fanti S, Herrmann K. 68Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline for prostate cancer imaging: version 1.0. Eur J Nucl Med Mol Imaging. 2017 Jun;44(6):1014-1024. doi: 10.1007/s00259-017-3670-z.
Results Reference
background
PubMed Identifier
30530831
Citation
Hope TA, Goodman JZ, Allen IE, Calais J, Fendler WP, Carroll PR. Metaanalysis of 68Ga-PSMA-11 PET Accuracy for the Detection of Prostate Cancer Validated by Histopathology. J Nucl Med. 2019 Jun;60(6):786-793. doi: 10.2967/jnumed.118.219501. Epub 2018 Dec 7.
Results Reference
background
PubMed Identifier
23179945
Citation
Afshar-Oromieh A, Malcher A, Eder M, Eisenhut M, Linhart HG, Hadaschik BA, Holland-Letz T, Giesel FL, Kratochwil C, Haufe S, Haberkorn U, Zechmann CM. PET imaging with a [68Ga]gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of tumour lesions. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):486-95. doi: 10.1007/s00259-012-2298-2. Epub 2012 Nov 24. Erratum In: Eur J Nucl Med Mol Imaging. 2013 May;40(5):797-8.
Results Reference
background
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68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly)
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