Phase 2
Completed N=14
68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
Source: ClinicalTrials.gov NCT03949517 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained — 14; 14 Participants
Summary
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained |
14; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Known prostate cancer
- Planned HIFU or HDR local therapy
- Able to provide written consent
- Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Exclusion Criteria
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Metallic implants (contraindicated for MRI)
Data sourced from ClinicalTrials.gov (NCT03949517). 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. Informational only — not medical advice.