Clinical trial NCT02918357: Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Official title: Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 385
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: The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Detailed description: Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Eligibility criteria: Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

  * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

    * PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
    * Confirmatory persistent PSA greater than 0.2 ng/mL
  * Post-radiation therapy -ASTRO-Phoenix consensus definition

    * Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
* Age \> 18.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a PET scan.
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
* Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

Primary outcomes:
measure: Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
timeFrame: 1 month
measure: Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
timeFrame: 1 month
Secondary outcomes:
measure: PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
timeFrame: 1 month
measure: PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
timeFrame: 1 month
measure: Sensitivity on a Per-patient Basis
timeFrame: 1 month
measure: Sensitivity on a Per-region Basis
timeFrame: 1 month
measure: Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
timeFrame: 1 month
measure: Inter-reader Agreement Per-region
timeFrame: 1 month
measure: Percentage of Participants With Change in Clinical Management
timeFrame: Up to 1 year
measure: Safety Assessment - Heart Rate
timeFrame: 1 day
measure: Safety Assessment - Blood Pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: