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.
- Drug: Gallium Ga 68 DOTA-NeoBOMB1
- Device: Gallium Ga 68 PSMA-R2
- 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)
(i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical
(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).
- 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
- Metallic implants (contraindicated for magnetic resonance imaging [MRI]).
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study