- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822845
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence
This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.
To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.
The 68Ga PSMA will be tested in men who have biochemical recurrence of prostate cancer after surgery or radiation treatment. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan.
Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or biopsy result does not.
The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- The University of Iowa Hospitals & Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ability to understand and willingness to provide informed consent.
- Pathologically proven prostate adenocarcinoma.
- Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
- If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weeks post-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.
- If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL rise above the lowest PSA value ('nadir').
- A PSA level result within the last 2 months meeting criteria above.
- Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations).
- 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).
- Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.
Exclusion Criteria:
- Cannot receive furosemide.
- History of Stevens-Johnson syndrome.
- History or diagnosis of Paget's disease.
- Malignancy other than current disease under study.
- Allergy to sulfa or sulfa-containing medications.
- 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
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 68Ga PSMA PET scan
Ga-68 PSMA-HBED-CC PET/CT scan
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Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors.
The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine sensitivity on a per-patient basis of 68Ga PSMA PET scans for detection of tumor location [CT.gov: ref: NCT03389451 for all comments]
Time Frame: Up to 12 months after the 68Ga PSMA PET scan
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Sensitivity will be determined on a per-patient basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
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Up to 12 months after the 68Ga PSMA PET scan
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Determine sensitivity on a per-region basis of 68Ga PSMA PET scans for detection of tumor location
Time Frame: Up to 12 months after the 68Ga PSMA PET scan
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Sensitivity will be determined on a per-region basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
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Up to 12 months after the 68Ga PSMA PET scan
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location
Time Frame: 3 and 12 months after 68Ga PSMA PET scan
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Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
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3 and 12 months after 68Ga PSMA PET scan
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Evaluate adverse events of 68Ga PSMA PET scan
Time Frame: through 24 hours post-injection of 68Ga PSMA
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Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03
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through 24 hours post-injection of 68Ga PSMA
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Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology.
Time Frame: 3 and 12 months after 68Ga PSMA PET scan
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Sensitivity value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
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3 and 12 months after 68Ga PSMA PET scan
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Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT when stratified by PSA value
Time Frame: 3 and 12 months after 68Ga PSMA PET scan
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Detection rates will be evaluated on a per-subject basis, stratified by PSA values: 0.2 - <0.5, 0.5 - <1.0, 1.0 <2.0, 2.0 - <5.0, 5.0 or greater
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3 and 12 months after 68Ga PSMA PET scan
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael M Graham, Ph.D., MD, University of Iowa
Publications and helpful links
General Publications
- van Leeuwen PJ, Emmett L, Ho B, Delprado W, Ting F, Nguyen Q, Stricker PD. Prospective evaluation of 68Gallium-prostate-specific membrane antigen positron emission tomography/computed tomography for preoperative lymph node staging in prostate cancer. BJU Int. 2017 Feb;119(2):209-215. doi: 10.1111/bju.13540. Epub 2016 Jun 18.
- Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kubler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J Nucl Med. 2015 May;56(5):668-74. doi: 10.2967/jnumed.115.154153. Epub 2015 Mar 19. Erratum In: J Nucl Med. 2016 Aug;57(8):1325.
- Maurer T, Gschwend JE, Rauscher I, Souvatzoglou M, Haller B, Weirich G, Wester HJ, Heck M, Kubler H, Beer AJ, Schwaiger M, Eiber M. Diagnostic Efficacy of (68)Gallium-PSMA Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer. J Urol. 2016 May;195(5):1436-1443. doi: 10.1016/j.juro.2015.12.025. Epub 2015 Dec 9.
- Afshar-Oromieh A, Avtzi E, Giesel FL, Holland-Letz T, Linhart HG, Eder M, Eisenhut M, Boxler S, Hadaschik BA, Kratochwil C, Weichert W, Kopka K, Debus J, Haberkorn U. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):197-209. doi: 10.1007/s00259-014-2949-6. Epub 2014 Nov 20.
- Green MA, Eitel JA, Fletcher JW, Mathias CJ, Tann MA, Gardner T, Koch MO, Territo W, Polson H, Hutchins GD. Estimation of radiation dosimetry for 68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer. Nucl Med Biol. 2017 Mar;46:32-35. doi: 10.1016/j.nucmedbio.2016.11.002. Epub 2016 Nov 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Disease Attributes
- Genital Neoplasms, Male
- Prostatic Diseases
- Neoplasms
- Prostatic Neoplasms
- Recurrence
- Prostatic Neoplasms, Castration-Resistant
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Edetic Acid
- Gallium 68 PSMA-11
Other Study ID Numbers
- 201810754
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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