PSMA-PET + MRI for Prostate Cancer

Overseen By Jennifer Lehman

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Five Eleven Pharma, Inc.

Disqualifiers: Other trials, MRI safety, significant illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a PSMA-PET scan (a type of imaging test) to the usual MRI before prostate cancer surgery can improve patient outcomes. Researchers aim to determine if this combination provides doctors with better information for surgical planning, potentially leading to improved recovery and results for patients. The trial compares two groups: one receiving only the standard MRI and another receiving both the MRI and PSMA-PET. Men with significant prostate cancer who plan to undergo prostate surgery and wish to preserve sexual function may be suitable for this study. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer surgery planning.

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.

What prior data suggests that PSMA-PET and SOC MRI are safe for prostate cancer patients?

Research has shown that PSMA-PET imaging is generally safe for patients. One study using 68Ga-THP PSMA, a specific type of PSMA-PET, reported no serious side effects, and no participants withdrew due to side effects. Another study found that 68Ga-PSMA-11, another variant, was well-tolerated and safe for patients with prostate cancer. These findings suggest that PSMA-PET, when combined with standard MRI, serves as a safe and well-tolerated diagnostic tool for prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PSMA-PET combined with SOC MRI for prostate cancer because it offers a more precise imaging technique compared to the standard of care. PSMA-PET targets a protein often found in higher amounts on prostate cancer cells, potentially allowing for more accurate detection and staging of the disease. This method could lead to better surgical planning and outcomes, as it may reveal cancer spread that traditional MRI might miss. By enhancing the visibility of cancerous tissues, this technique aims to improve treatment decisions and overall patient care.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that PSMA-PET scans effectively detect prostate cancer. One study revealed that PSMA-PET/CT scans altered the cancer stage in 45% of cases, often leading to different treatment plans. Another study found that these scans correctly identified cancer in 94% of patients. In this trial, some participants will undergo both PSMA-PET and SOC MRI before surgery, while others will receive only SOC MRI. PSMA-PET can also detect tumors early, potentially improving treatment outcomes. This imaging method is promising because it aids doctors in making better decisions for managing prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

Group I: PSMA-PET and SOC MRI prior to surgery Experimental Treatment 1 Intervention

Group II: SOC MRI prior to surgery Active Control 1 Intervention

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

Approved in United States as PSMA-PET for:

• Detection of prostate cancer spread
• Staging of prostate cancer
• Localization of recurrent prostate cancer

Approved in European Union as PSMA-PET for:

• Initial staging of prostate cancer
• Localization of recurrent prostate cancer
• Staging before PSMA-directed radioligand therapy

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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-11, developed by UCLA and UCSF, received FDA approval on December 1, 2020, as the first drug specifically for PET imaging of prostate cancer lesions, marking a significant advancement in prostate cancer diagnostics.

The approval followed a pivotal phase 3 clinical trial, highlighting the drug's efficacy in identifying PSMA-positive lesions, which is crucial for improving treatment planning in men with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership. Carlucci, G., Ippisch, R., Slavik, R., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 54 patients, combining 68Ga-PSMA PET/CT with multiparametric MRI (PET/MRI) significantly improved the detection of clinically significant prostate cancer compared to MRI alone, with a sensitivity increase from 76% to 89%.

PET/MRI showed better diagnostic performance for lesions classified as PI-RADS 3, indicating that this combination imaging technique can enhance the identification of potentially serious prostate cancer without compromising specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of 68Ga-PSMA PET/CT and Multiparametric MRI Improves the Detection of Clinically Significant Prostate Cancer: A Lesion-by-Lesion Analysis. Chen, M., Zhang, Q., Zhang, C., et al.[2021]

In a pilot study of 62 patients with suspected or defined prostate cancer, PSMA-PET/MRI imaging led to a change in management strategies for 41.9% of patients, indicating its potential clinical utility in guiding treatment decisions.

The most significant impact of PSMA-PET/MRI was observed in patients with biochemical recurrent prostate cancer, particularly those with PSA levels between 0.5 and 1 ng/ml, suggesting that this imaging technique can help refine treatment approaches in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. Liu, A., Zhang, M., Huang, H., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Afaq, A., Payne, H., Davda, R., et al.[2022]

Targeted iron oxide nanoparticles (TBNPs and TDNPs) using PSMA-11 peptides showed significantly enhanced MRI contrast for detecting prostate cancer tumors in a mouse model, achieving up to 88.6% relative signal enhancement compared to muscle tissue.

The study suggests that using targeted nanoparticles allows for a reduction in the required dose of non-targeted iron oxide nanoparticles, making the detection process more efficient and potentially safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular MR Imaging of Prostate Cancer by Specified Iron Oxide Nanoparticles With PSMA-11 Peptides: A Preclinical Study. Ghorbani, F., Aminzadeh, B., Borji, N., et al.[2023]

The study demonstrated that a comprehensive whole-body 18F-PSMA-1007-PET/MRI protocol is feasible and reproducible for imaging prostate cancer in eight high-risk patients, effectively detecting dominant lesions and providing complementary staging information.

The results showed strong correlation between SUVmean values from PET/CT and PET/MRI, indicating that this combined imaging approach can enhance the accuracy of prostate cancer assessment while minimizing artifacts, thus improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Freitag, MT., Kesch, C., Cardinale, J., et al.[2019]

The guideline aims to standardize the use of 68Ga-PSMA PET/CT imaging for prostate cancer, enhancing its accuracy and reliability in both research and clinical settings.

By establishing clear recommendations for the performance and reporting of this imaging technique, the guideline seeks to improve the overall effectiveness of prostate cancer diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline for prostate cancer imaging: version 1.0. Fendler, WP., Eiber, M., Beheshti, M., et al.[2022]

In a study of 144 patients, 68Ga-PSMA PET/CT showed a slightly lower sensitivity (83.1%) compared to mpMRI (90.1%) for detecting prostate cancer lesions, but it was more effective at identifying larger lesions that mpMRI missed.

68Ga-PSMA PET/CT provided additional detection of prostate cancer lesions, identifying 13.5% more index lesions and 18.2% more total lesions compared to mpMRI, suggesting it offers incremental value in the diagnostic process for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT better characterises localised prostate cancer after MRI and transperineal prostate biopsy: Is 68Ga-PSMA PET/CT guided biopsy the future? Donato, P., Morton, A., Yaxley, J., et al.[2021]

In a study of ten patients with primary prostate cancer, both multi-parametric MRI (MP-MRI) and PSMA-PET/CT effectively identified tumor locations, showing high agreement in tumor staging based on biopsy results.

PSMA-PET/CT demonstrated a strong correlation with MP-MRI, identifying tumors in 89.4% of sections marked by MP-MRI and 96.8% of sections marked by PSMA-PET, suggesting that PSMA-PET/CT could be a reliable alternative for staging prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of (68)Ga-PSMA-11-PET/CT and multi-parametric MR for imaging of primary prostate cancer. Giesel, FL., Sterzing, F., Schlemmer, HP., et al.[2022]

PSMA PET/MRI is a promising imaging technique for detecting primary prostate cancer, showing higher accuracy compared to traditional multiparametric MRI.

This imaging modality is also effective for restaging and detecting tumor recurrence in prostate cancer patients, even when prostate-specific antigen levels are low, although more research is needed to establish definitive recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Manfredi, C., Fernández-Pascual, E., Arcaniolo, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11394562/

Comparative Performance of 68Ga-PSMA-11 PET/CT and ... Overall, PSMA-PET/CT led to a TNM upstaging in 45.0% (27/60) of cases, with no evidence of downstaging, resulting in a change in management in ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251888

Impact of 68Ga-PSMA-11 PET/CT on Clinical Management of ... 68 Ga-PSMA-11 PET/CT is a promising diagnostic tool in the work-up of PCa patients in the real world, demonstrating an overall positivity rate of 94%.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36900169/

Detection Efficacy of 68 Ga-PSMA-11 PET/CT in ... In biochemical recurrence of prostate cancer (BCR), prompt tumor localization guides early treatment, potentially improving patient outcomes.

4. nature.com nature.com/articles/s41598-024-65399-1

Comparison of digital and analog [68Ga]Ga-PSMA-11 PET ... Analog and digital PET/CT showed comparable lesion detection rate (71.8% vs. 74.4%), sensitivity (85.0% vs. 90.0%), and positive predictive ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2588931124002517

Baseline Nodal Status on 68Ga-PSMA-11 Positron ... The use of prostate-specific membrane antigen (PSMA) PET-CT also led to greater treatment decision impact (28% vs 15%), fewer uncertain results ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612191/

A Phase II, Open-Label Study to Assess Safety and ... Conclusion: 68Ga-THP PSMA was safe to use, with no serious AEs and no AEs resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of ...

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233460

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ... Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11281955/

Evaluation of 68Ga-PSMA-11 PET/CT: a Phase 1 clinical ... 68 Ga-PSMA-11 has a favourable safety and tolerability profile in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02282137

Study Details | NCT02282137 | 68Ga-PSMA PET-CT Scan ... 68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828651

PSMA-PET/CT Findings in Patients With High-Risk ... PSMA-PET results were positive in 84% of patients, PSMA-PET detected M1 disease stage in 46% of patients and found polymetastatic disease (≥5 lesions) in 24% ...