Clinical trial NCT04777071: An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer
Official title: 68Ga-PSMA-11 PET in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Biochemically Recurrent Prostate Carcinoma
Metastatic Castration-Resistant Prostate Carcinoma
Prostate Adenocarcinoma
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Keywords: Prostate
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 213
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.

After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.

Eligibility 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

Primary outcomes:
measure: Change in planned management strategy
timeFrame: Baseline up to 1.5 years after the last scan
Secondary outcomes:
measure: Major change in management
timeFrame: Baseline up to 5 years post-scan
measure: Minor change in management
timeFrame: Baseline up to 5 years post-scan
measure: 68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
timeFrame: Up to 6 weeks after systemic therapy initiation
measure: 68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
timeFrame: Up to 6 weeks after systemic therapy initiation
measure: Change in 68Ga-PSMA-11 SUVmax
timeFrame: Baseline up to 6 weeks after systemic therapy initiation
measure: Change in 68Ga-PSMA-11 SULpeak
timeFrame: Baseline up to 6 weeks after systemic therapy initiation
measure: Change in size of measurable metastatic lesions
timeFrame: Baseline up to 5 years post-scan
measure: Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens
timeFrame: Up to 5 years post-scan
measure: Change in PSMA total tumor volume
timeFrame: Baseline up to 5 years post-scan
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Delphine L. Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: