68Ga-RM2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-contributory CT Scans


Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02624518

Sponsor: Andrei Iagaru

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov