Trial Search Results

68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer

This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic resonance imaging (MRI) works in detecting prostate cancer in patients with negative computed tomography (CT) scan and elevated prostate-specific antigen levels after treatment with surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and combine them into a single picture and is used to describe information regarding the function, as well as location and size of a tumor. 68Ga-RM2, a compound made of a radioactive agent linked to a pharmacological substance that is strongly attracted by a substance made by tumor cells, to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Andrei Iagaru

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - Biopsy proven prostate adenocarcinoma

   - Rising 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 6-13 weeks after RP

         - Confirmatory persistent PSA greater than 0.2 ng/mL

      - Post-radiation therapy - American Society for Therapeutic Radiology and Oncology
      (ASTRO)-Phoenix consensus definition

         - Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA

   - No evidence of metastatic disease on conventional imaging, including a negative bone
   scan for skeletal metastasis and negative contrast-enhanced CT

   - Able to provide written consent

   - Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
   [ECOG]/World Health Organization [WHO] equivalent)

Exclusion Criteria:

   - Unable to provide informed consent

   - Inability to lie still for the entire imaging time

   - Inability to complete the needed investigational and standard-of-care imaging
   examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

   - Any additional medical condition, serious intercurrent illness, or other extenuating
   circumstance that, in the opinion of the investigator, may significantly interfere
   with study compliance

   - Metallic implants

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pamela Gallant
650-725-6409
Recruiting