Trial Outcomes & Findings for High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy (NCT NCT04461509)

Last Updated: 2026-03-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

At time of pre-HIFU biopsy

Results posted on

2026-03-25

Participant Flow

The trial opened to accrual on 04/06/2021 with first subject enrolled on study 04/06/2021. Recruitment occurred at Cedars-Sinai Medical Center.

Participant milestones

Participant milestones
Measure	ARM 1 (HIFU) - 18F-PSMA 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer	ARM 2 (RP) - 18F-PSMA 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer
Overall Study STARTED	29	33
Overall Study COMPLETED	24	32
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM 1 (HIFU) - 18F-PSMA n=24 Participants 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer	ARM 2 (RP) - 18F-PSMA n=32 Participants 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=138 Participants	17 Participants n=62 Participants	27 Participants n=123 Participants
Age, Categorical >=65 years	14 Participants n=138 Participants	15 Participants n=62 Participants	29 Participants n=123 Participants
Sex: Female, Male Female	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Sex: Female, Male Male	24 Participants n=138 Participants	32 Participants n=62 Participants	56 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=138 Participants	3 Participants n=62 Participants	5 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=138 Participants	28 Participants n=62 Participants	50 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=138 Participants	1 Participants n=62 Participants	1 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	5 Participants n=138 Participants	7 Participants n=62 Participants	12 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	3 Participants n=138 Participants	1 Participants n=62 Participants	4 Participants n=123 Participants
Race (NIH/OMB) White	15 Participants n=138 Participants	23 Participants n=62 Participants	38 Participants n=123 Participants
Race (NIH/OMB) More than one race	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=138 Participants	1 Participants n=62 Participants	2 Participants n=123 Participants
Region of Enrollment United States	24 participants n=138 Participants	32 participants n=62 Participants	56 participants n=123 Participants

PRIMARY outcome

Timeframe: At time of pre-HIFU biopsy

Population: The number of participants analyzed is 32 and not 29, because some participants switched over to the RP arm after already completing study intervention (imaging).

Outcome measures

Outcome measures
Measure	ARM 1 (HIFU) - 18F-PSMA n=192 biopsy-zones 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer Difference between sensitivities to identify prostate lesions.
Primary Endpoint (HIFU): Identification of New Cancers Gleason 6+	85 biopsy-proven cancerous zones
Primary Endpoint (HIFU): Identification of New Cancers Gleason 7+	49 biopsy-proven cancerous zones

PRIMARY outcome

Timeframe: preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery

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.

Outcome measures

Outcome measures
Measure	ARM 1 (HIFU) - 18F-PSMA n=32 Participants 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer Difference between sensitivities to identify prostate lesions.
Primary Endpoint (HIFU):	8 Participants

SECONDARY outcome

Timeframe: 6 months following standard HIFU therapy

Population: Negative for any cancer in treated area, including high and low grade cancer 17/22 (77.3%) Negative for high-grade cancer in treated area 18/22 (81.8%) There were 4/22 patients who had high grade cancer in the treated area, and one patient who had low grade cancer in the treated area. Hence, 18/22 were negative for high grade cancer in the treated area while 17/22 were negative for both high grade or low grade cancer.

Negative biopsy rate on systematic and targeted biopsy 6 months following HIFU therapy. Data presented are from both systematic + targeted biopsy as a single unit. For example, a positive biopsy from a given area of the prostate could have come from either systematic or targeted cores.

Outcome measures

Outcome measures
Measure	ARM 1 (HIFU) - 18F-PSMA n=22 Participants 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer Difference between sensitivities to identify prostate lesions.
Secondary Endpoint (HIFU): Negative for any cancer in treated area, including high and low grade cancer	17 Participants
Secondary Endpoint (HIFU): Negative for high-grade cancer in treated area	18 Participants

SECONDARY outcome

Timeframe: 6 months following standard HIFU therapy

Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: After study completion, an average of 6 months

RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.

Outcome measures

Outcome data not reported

Adverse Events

ARM 1 (HIFU) - 18F-PSMA

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

ARM 2 (RP) - 18F-PSMA

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARM 1 (HIFU) - 18F-PSMA n=24 participants at risk 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer	ARM 2 (RP) - 18F-PSMA n=32 participants at risk 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer
Respiratory, thoracic and mediastinal disorders SOB	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Blood and lymphatic system disorders Hematoma	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Gastrointestinal disorders Sigmoid Diverticulitis	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Hepatobiliary disorders Abdominal Wall Fluid Collection	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
General disorders Fever	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Renal and urinary disorders Hematuria	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Renal and urinary disorders Urinary Retention	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
General disorders Intractable Back Pain	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.

Other adverse events

Additional Information

Laura Sarmiento

Cedars-Sinai Medical Center

Phone: 310-423-4295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ARM 1 (HIFU) - 18F-PSMA n=24 participants at risk 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer	ARM 2 (RP) - 18F-PSMA n=32 participants at risk 10 mCi ±20% F18-PSMA injection 18F-PSMA: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer
General disorders Syncope Post-Chemo	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
General disorders Fever Post-Chemo	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Infections and infestations Urinary Tract Infection	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	6.2% 2/32 • Number of events 2 • Through study completion, an average of 6 months.
General disorders Abdominal Pain	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Hepatobiliary disorders Increased ALT (Alanine aminotransferase)	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Blood and lymphatic system disorders Anemia	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
General disorders Perineal Pain	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Renal and urinary disorders Urinary Retention	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Renal and urinary disorders Urinary Incontinence	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
General disorders Right Groin Pain	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Nervous system disorders Hyponatremia	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Renal and urinary disorders Bladder Discomfort	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Renal and urinary disorders Burning Urination for One Week	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Skin and subcutaneous tissue disorders Facial Rash	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Musculoskeletal and connective tissue disorders Osteoarthritis of Left Knee	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Musculoskeletal and connective tissue disorders Effusion of Left Knee	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
General disorders Tongue Swelling - Allergic Reaction to Contrast	4.2% 1/24 • Number of events 1 • Through study completion, an average of 6 months.	0.00% 0/32 • Through study completion, an average of 6 months.
Vascular disorders Acute DVT (Deep Vein Thrombosis) Right Femoral Vein	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Respiratory, thoracic and mediastinal disorders Hypoxemia	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Blood and lymphatic system disorders Acute Blood Loss Anemia	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.
Infections and infestations Septecemia	0.00% 0/24 • Through study completion, an average of 6 months.	3.1% 1/32 • Number of events 1 • Through study completion, an average of 6 months.