68Ga-PSMA-11 PET in Patients With Prostate Cancer
Condition: Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04777071
Sponsor: University of Washington
Phase: Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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
- 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
View trial on ClinicalTrials.gov