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18F-PSMA · 1 trial · 7 indications
The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.
The primary endpoint of the Phase II study is to assess the number of participants with biopsy-proven cancers that mpMRI would have missed compared with hrMRI and/or F18-PSMA PET.
| Arm | Type | Description |
|---|---|---|
| ARM 1 (HIFU) - 18F-PSMA | EXPERIMENTAL | 10 mCi ±20% F18-PSMA injection |
| ARM 2 (RP) - 18F-PSMA | EXPERIMENTAL | 10 mCi ±20% F18-PSMA injection |
| Name | Type | Description |
|---|---|---|
| 18F-PSMA | DRUG | Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer |
Inclusion Criteria: 1. Biopsy consisting of ≥ 10 tissue cores sampled 2. PSA \<20 ng/mL (for HIFU arm only) 3. cT1-cT2c 4. Either overall Gleason score \> 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with \> half of systematic biopsy co...
18F-PSMA is an investigational small molecule being studied for use in prostatic neoplasms, or prostate cancer. It is a positron emission tomography (PET) imaging agent designed to detect prostate cancer lesions. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
18F-PSMA targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. By binding to PSMA, the radiolabeled molecule enables PET imaging to visualize prostate cancer lesions. This targeting mechanism is the basis for its potential use in detecting and staging prostate cancer.
18F-PSMA is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. Lantheus is responsible for the clinical development of this investigational imaging agent for prostate cancer.
18F-PSMA is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is still undergoing clinical trials to evaluate its safety and effectiveness for imaging prostate cancer.
18F-PSMA has one completed Phase 2 clinical trial, identified as NCT04461509. This study, titled 'High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy,' enrolled 62 male participants aged 18 years and older in the United States. The trial was controlled but not randomized or double-blinded.
18F-PSMA is a specific radiotracer used in PSMA PET imaging. While PSMA PET refers to the imaging technique that uses various PSMA-targeting tracers, 18F-PSMA is the particular investigational compound developed by Lantheus. It is not the same as other PSMA PET agents, such as 68Ga-PSMA-11.