Imaging prostate cancer with a special PET scan
68Ga-PSMA-11 PET in Patients With Prostate Cancer
PHASE2 · University of Washington · NCT04777071
This study is testing a special PET scan to see if it can better detect and monitor prostate cancer in patients at different stages of the disease.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 213 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Washington (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04777071 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the 68Ga-PSMA-11 PET scan in imaging patients with various stages of prostate cancer. Participants will receive an intravenous injection of gallium Ga 68-labeled PSMA-11 and undergo PET/CT or PET/MR scans to assess the scan's ability to detect and monitor prostate cancer. Patients receiving systemic therapy will have additional scans after 12 weeks of treatment. Follow-up assessments will occur at 60 days, 6 months, and annually for up to 5 years or until disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically proven prostate adenocarcinoma, particularly those with high-risk characteristics or biochemical recurrence after prior treatments.
Not a fit: Patients without a confirmed diagnosis of prostate adenocarcinoma or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could enhance the detection and monitoring of prostate cancer, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promising results with similar imaging approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort) * No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed) * Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status grades 0, 1, or 2 * Ability to understand and willingness to provide informed consent Exclusion Criteria: * 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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Delphine L. Chen, M.D. — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Akshata Mathur
- Email: psmaresearch@uw.edu
- Phone: 206.667.5801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Prostate