68Ga-PSMA-11 PET in Patients With Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT05197257 |
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Recruitment Status :
Recruiting
First Posted : January 19, 2022
Last Update Posted : April 7, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Prostate Adenocarcinoma | Drug: Ga-PSMA-11 | Phase 3 |
This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.
Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.
One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | 68Ga-PSMA-11 PET in Patients With Prostate Cancer |
| Actual Study Start Date : | April 5, 2022 |
| Estimated Primary Completion Date : | May 2025 |
| Estimated Study Completion Date : | May 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Men with pathologically proven prostate adenocarcinoma
The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
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Drug: Ga-PSMA-11
The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment. |
- Grade and record incidence of Adverse Events (AEs) to measure safety of Ga-PSMA-11 [ Time Frame: 4 years ]Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.
- Grade and record incidence of Adverse Events (AEs) to measure tolerability of Ga-PSMA-11 [ Time Frame: 4 years ]Adverse Events (AEs) will be collected and reviewed. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.
- Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans [ Time Frame: 4 years ]Results will be summarized descriptively with 95% confidence intervals. Determine rate of major and minor changes in management by comparing planned management strategy using conventional imaging and executed management strategy incorporating information from 68Ga-PSMA-11 PET/CT, regardless of treatment modality.
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histopathologically proven prostate adenocarcinoma
- Age ≥ 18 years
- Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
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Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):
a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
- Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
- Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
- Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.
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): NCT05197257
| Contact: Aaron Mobley | 13037245693 | aaron.mobley@cuanschutz.edu |
| United States, Colorado | |
| Colorado Research Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Aaron Mobley 720-848-5523 aaron.mobley@cuanschutz.edu | |
| Sub-Investigator: Jennifer Kwak | |
| Sub-Investigator: Rustain Morgan | |
| UCHealth-Metro Denver | Recruiting |
| Denver, Colorado, United States, 80217-3364 | |
| Contact: Aaron Mobley 720-848-5523 aaron.mobley@cuanschutz.edu | |
| Principal Investigator: | Bennett Chin | Colorado Research Center |
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT05197257 |
| Other Study ID Numbers: |
21-4070.cc |
| First Posted: | January 19, 2022 Key Record Dates |
| Last Update Posted: | April 7, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Newly Diagnosed |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Gallium 68 PSMA-11 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |