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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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). a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation. (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy. (ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL). b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition. (i) A rise of PSA measurement of 2 or more ng/mL over the nadir. - 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]).


Andrei Iagaru
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)

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Andrei Iagaru