Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

Trial ID or NCT#

NCT03698370

Status

not recruiting iconNOT RECRUITING

Purpose

This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

Official Title

68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Biopsy proven prostate adenocarcinoma.* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
    1. a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation.
      1. (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.
      2. (ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).
    2. b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.
      1. (i) A rise of PSA measurement of 2 or more ng/mL over the nadir.
  2. * Able to provide written consent.* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent).
Exclusion Criteria:
  1. * 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.* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.* Metallic implants (contraindicated for magnetic resonance imaging \[MRI\]).
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Investigator(s)

Andrei Iagaru
Andrei Iagaru
Radiologist
Professor of Radiology (Nuclear Medicine)

Contact us to find out if this trial is right for you.

Contact

Andrei Iagaru
650-725-4711

View on ClinicalTrials.gov