288 Participants Needed

PSMA-PET + MRI for Prostate Cancer

CD
JL
Overseen ByJennifer Lehman
Age: 18+
Sex: Male
Trial Phase: Phase 2 & 3
Sponsor: Five Eleven Pharma, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is comparing two groups of patients undergoing surgery. One group will receive the usual imaging scan, while the other group will get an additional special scan that uses a dye to make cancer cells more visible. This new imaging method may help doctors plan surgeries better and improve patient outcomes.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is PSMA-PET + MRI safe for use in humans?

Research shows that 68Ga-THP PSMA PET/CT, a similar imaging method, is generally safe in humans, with no serious adverse events reported. Some minor side effects like itching and rash at the injection site were noted, but no participants had to leave the study because of these effects.12345

How is the PSMA-PET + MRI treatment different from other prostate cancer treatments?

The PSMA-PET + MRI treatment is unique because it combines advanced imaging techniques to better detect and stage prostate cancer. This approach uses a special imaging agent, 68Ga-PSMA-11, which targets prostate-specific membrane antigen (PSMA) to provide more accurate and detailed images than traditional methods, helping to identify cancer spread more effectively.678910

What data supports the effectiveness of the treatment PSMA-PET + MRI for prostate cancer?

Research shows that combining PSMA-PET with MRI improves the detection of significant prostate cancer compared to using MRI alone. This combination has high sensitivity, meaning it is very good at correctly identifying patients with prostate cancer, especially for certain types of lesions.910111213

Who Is on the Research Team?

CB

Clinton Bahler, MD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

Men with significant prostate cancer planning to undergo surgery can join. They should have a certain level of prostate cancer severity, based on Gleason scores, and wish to maintain erections post-treatment. Men with any serious health issues, participating in other radiation trials recently, or unable to stay still for imaging due to physical limits or claustrophobia cannot participate.

Inclusion Criteria

I want to keep my ability to have erections after treatment.
My prostate cancer is aggressive based on my biopsy results.
I am a man with prostate cancer opting for surgery to remove my prostate.
See 1 more

Exclusion Criteria

I cannot stay still on a PET or MRI machine due to physical issues or claustrophobia.
I do not have any major health issues that could interfere with the study.
Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Imaging

Participants undergo standard of care MRI and possibly PSMA PET scan prior to surgery

1 month

Surgery

Participants undergo prostatectomy surgery with surgical plans potentially influenced by imaging findings

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of incontinence, erectile function, and overall health

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • PSMA-PET and SOC MRI
  • SOC MRI
Trial Overview The trial is testing if adding a PSMA-PET scan alongside the standard MRI before surgery provides better information than just the MRI alone. The study will see if this extra scan changes surgical plans and improves outcomes by comparing two groups: one gets only an MRI and the other gets both an MRI and PSMA-PET.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PSMA-PET and SOC MRI prior to surgeryExperimental Treatment1 Intervention
Group II: SOC MRI prior to surgeryActive Control1 Intervention

PSMA-PET and SOC MRI is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as PSMA-PET for:
  • Detection of prostate cancer spread
  • Staging of prostate cancer
  • Localization of recurrent prostate cancer
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as PSMA-PET for:
  • Initial staging of prostate cancer
  • Localization of recurrent prostate cancer
  • Staging before PSMA-directed radioligand therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Five Eleven Pharma, Inc.

Lead Sponsor

Trials
6
Recruited
410+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

Published Research Related to This Trial

In a study of 79 men with newly diagnosed prostate cancer, 18F-PSMA-1007 PET/CT demonstrated a significantly higher sensitivity (87%) for detecting pelvic lymph node metastases compared to whole-body MRI with diffusion-weighted imaging (45%) and standard CT (26%).
The 18F-PSMA-1007 PET/CT maintained high specificity (98%), indicating it is a more effective imaging modality for primary nodal staging in prostate cancer while accurately identifying malignant lymph nodes that other methods missed.
Prospective comparison of 18F-PSMA-1007 PET/CT, whole-body MRI and CT in primary nodal staging of unfavourable intermediate- and high-risk prostate cancer.Malaspina, S., Anttinen, M., Taimen, P., et al.[2023]
PSMA PET/MRI is more accurate than traditional methods like multiparametric MRI and PET alone for diagnosing primary prostate cancer, based on a systematic review of 10 studies.
The pooled sensitivity of PSMA PET/MRI in detecting primary prostate cancer is very high at 97.6%, indicating it is particularly effective, especially for patients with PIRADS 3 lesions.
Systematic Review and Metanalysis on the Role of Prostate-Specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging for Intraprostatic Tumour Assessment.Mapelli, P., Ghezzo, S., Spataro, A., et al.[2023]
68Ga-PSMA PET/MRI has demonstrated high diagnostic accuracy for staging primary prostate cancer, showing equivalent effectiveness to 68Ga-PSMA PET/CT in detecting critical features like extracapsular extension, seminal vesicle invasion, and lymph node metastasis.
The analysis included 27 studies, indicating that while both imaging modalities are effective, further direct comparisons are necessary to fully establish the advantages of 68Ga-PSMA PET/MRI over PET/CT in clinical practice.
Comparison of 68Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Magnetic Resonance Imaging and Positron Emission Tomography/Computed Tomography for Primary Staging of Prostate Cancer: A Systematic Review and Meta-analysis.Ling, SW., de Jong, AC., Schoots, IG., et al.[2022]

Citations

Prospective comparison of 18F-PSMA-1007 PET/CT, whole-body MRI and CT in primary nodal staging of unfavourable intermediate- and high-risk prostate cancer. [2023]
Systematic Review and Metanalysis on the Role of Prostate-Specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging for Intraprostatic Tumour Assessment. [2023]
Comparison of 68Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Magnetic Resonance Imaging and Positron Emission Tomography/Computed Tomography for Primary Staging of Prostate Cancer: A Systematic Review and Meta-analysis. [2022]
Combination of 68Ga-PSMA PET/CT and Multiparametric MRI Improves the Detection of Clinically Significant Prostate Cancer: A Lesion-by-Lesion Analysis. [2021]
Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. [2022]
A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. [2022]
Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. [2019]
68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership. [2022]
68Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline for prostate cancer imaging: version 1.0. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Molecular MR Imaging of Prostate Cancer by Specified Iron Oxide Nanoparticles With PSMA-11 Peptides: A Preclinical Study. [2023]
Intra-individual comparison of (68)Ga-PSMA-11-PET/CT and multi-parametric MR for imaging of primary prostate cancer. [2022]
The Role of Prostate-specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging in Primary and Recurrent Prostate Cancer: A Systematic Review of the Literature. [2022]
68Ga-PSMA PET/CT better characterises localised prostate cancer after MRI and transperineal prostate biopsy: Is 68Ga-PSMA PET/CT guided biopsy the future? [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity