Clinical trial NCT03353740: Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Official title: Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 346
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 its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.


Eligibility criteria: Inclusion Criteria

* Histopathologically proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

  * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy

    * PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
  * Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy

    * Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of \> 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

* Unable to lie flat, still or tolerate a PET scan.
* Concomitant investigational therapy.
* Patient undergoing active treatment for non-prostate malignancy, 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: True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
timeFrame: 1 day
Secondary outcomes:
measure: Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only
timeFrame: 1 Day
measure: True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only
timeFrame: 1 Day
measure: PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only
timeFrame: 1 Day
measure: Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
timeFrame: 1 Day
measure: Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment
timeFrame: 1 Day
measure: Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT)
timeFrame: 1 Day
measure: Percent of Participants With a Change in Clinical Management
timeFrame: Up to 6 months
measure: Rate of Inter-reader Reproducibility for Positivity
timeFrame: 1 Day
measure: Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events
timeFrame: Up to 30 days
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:
citation: Fendler WP, Calais J, Eiber M, Simko JP, Kurhanewicz J, Santos RD, Feng FY, Reiter RE, Rettig MB, Nickols NG, Kishan AU; PSMA PET Reader Group; Slavik R, Carroll PR, Lawhn-Heath C, Herrmann K, Czernin J, Hope TA. False positive PSMA PET for tumor remnants in the irradiated prostate and other interpretation pitfalls in a prospective multi-center trial. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):501-508. doi: 10.1007/s00259-020-04945-1. Epub 2020 Aug 17.
citation: Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.