Prostatic Neoplasms Clinical Trial
Official title:
Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence
Verified date | March 2023 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Iowa Hospitals & Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Michael Graham PhD, MD |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine sensitivity on a per-patient basis of 68Ga PSMA PET scans for detection of tumor location [CT.gov: ref: NCT03389451 for all comments] | 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. | Up to 12 months after the 68Ga PSMA PET scan | |
Primary | Determine sensitivity on a per-region basis of 68Ga PSMA PET scans for detection of tumor location | 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. | Up to 12 months after the 68Ga PSMA PET scan | |
Secondary | Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location | 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. | 3 and 12 months after 68Ga PSMA PET scan | |
Secondary | Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology. | 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. | 3 and 12 months after 68Ga PSMA PET scan | |
Secondary | Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT when stratified by PSA value | 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 | 3 and 12 months after 68Ga PSMA PET scan | |
Secondary | Evaluate adverse events of 68Ga PSMA PET scan | Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03 | through 24 hours post-injection of 68Ga PSMA |
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