An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer (NCT04777071) | Clinical Trial Compass
Active — Not RecruitingPhase 2
An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer
United States141 participantsStarted 2021-05-17
Plain-language summary
This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically proven prostate adenocarcinoma
* For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
* Grade group 4-5 and/or
* PSA \> 20 ng/mL
* For patients with biochemical recurrence (biochemical recurrence cohort):
* Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)
* If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence
* If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)
* For patients undergoing systemic therapy (treatment monitoring cohort):
* Diagnosis of metastatic castration-resistant prostate cancer
* At least one or more measurable ( \> 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days
* Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy
* This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not co…
What they're measuring
1
Change in planned management strategy
Timeframe: Baseline up to 1.5 years after the last scan