Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
Prostate Adenocarcinoma · PSA Progression · Recurrent Prostate Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03698370 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gallium Ga 68 DOTA-NeoBOMB1 (Drug); Gallium Ga 68 PSMA-R2 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Andrei Iagaru
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lesions Detected by Investigational Imaging Agent |
31; 20 | — |
| SECONDARY Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method |
18; 15 | — |
Summary
Eligibility Criteria
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]).
Data sourced from ClinicalTrials.gov (NCT03698370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.