Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Andrei Iagaru

Stanford Investigator(s):

Intervention(s):

  • Drug: Gallium Ga 68 DOTA-NeoBOMB1
  • Device: Gallium Ga 68 PSMA-R2

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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:

   - 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]).

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
Andrei Iagaru
650-725-4711
Recruiting