PSMA PET Scan for Prostate Cancer

Overseen By William Aronson, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: VA Greater Los Angeles Healthcare System

Disqualifiers: Under 18, Serious illness, others

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if adding a special scan to the usual prostate scan helps find significant prostate cancer better. It targets patients with high-risk prostate lesions. The special scan highlights cancer cells, which may improve detection when used with the regular scan. This new imaging method has shown promise as a noninvasive test to aid in the detection of significant prostate cancer while providing anatomical information to guide targeted procedures.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the PSMA PET Scan for Prostate Cancer treatment?

Research shows that PSMA PET scans, when combined with multiparametric MRI, are effective in accurately diagnosing and staging prostate cancer, which helps in better treatment planning. Studies have found that this combination can improve the detection and localization of prostate tumors compared to using MRI alone. ^{1 2 3 4 5}

Is the PSMA PET scan safe for humans?

The Phase I/IIa trial of 18F-PSMA 1007 PET/CT, which included healthy volunteers and prostate cancer patients, aimed to examine its safety, suggesting that safety data has been collected for this imaging method. ^{4 6 7 8 9}

How does the PSMA PET Scan for Prostate Cancer treatment differ from other treatments?

The PSMA PET Scan for Prostate Cancer treatment is unique because it combines PSMA PET imaging with multiparametric MRI (mpMRI) to improve the accuracy of detecting and localizing prostate cancer. This combination enhances the ability to delineate tumor extent better than using either imaging method alone, making it a promising option for precise cancer staging and treatment planning. ^{1 3 10 11 12}

Research Team

William Aronson, MD

Principal Investigator

VA Greater Los Angeles Healthcare System

Eligibility Criteria

This trial is for men with suspected clinically significant prostate cancer, indicated by a PI-RADS score of 4-5 from an mpMRI. Participants must have had this imaging within the last 9 months and be willing to undergo a biopsy. They should be able to consent and agree to random assignment in the study but cannot join if under 18 or have health issues that could affect their participation.

Inclusion Criteria

I have a high-risk prostate lesion and will have a biopsy.

I had a prostate MRI within the last 9 months.

I can sign and understand the consent form.

Exclusion Criteria

I am under 18 years old.

Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance

My kidney function is good enough for a prostate MRI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Imaging

Participants are randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy

1 week

Biopsy Procedure

Participants undergo fusion guided prostate biopsy based on mpMRI and PSMA scans or mpMRI alone

1 week

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

12 weeks

Treatment Details

Interventions

• mpMRI
• PSMA PET

Trial Overview The study is testing whether combining PSMA PET scans with mpMRI can better detect important prostate cancers compared to using mpMRI alone. It's a phase 2 trial where patients are randomly chosen to either get just an mpMRI or an additional DCFPyL PET/CT scan.

Participant Groups

Group I: PSMA PET+mpMRI Experimental Treatment 2 Interventions

PSMA PET+mpMRI guided prostate biopsy

Group II: mpMRI only Active Control 1 Intervention

mpMRI only guided prostate biopsy

mpMRI is already approved in European Union, United States for the following indications:

Approved in European Union as Multiparametric MRI for:

• Prostate cancer diagnosis
• Active surveillance of low-risk prostate cancer
• Risk stratification for targeted biopsy

Approved in United States as Multiparametric MRI for:

• Prostate cancer diagnosis
• Active surveillance of low-risk prostate cancer
• Risk stratification for targeted biopsy

Who Is Running the Clinical Trial?

VA Greater Los Angeles Healthcare System

Lead Sponsor

Trials

53

Recruited

8,700+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+

Findings from Research

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]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of prostate-specific membrane antigen PET and multiparametric MRI in the diagnosis of pretreatment patients with prostate cancer: a meta-analysis. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Primary staging in patients with intermediate- and high-risk prostate cancer: Multiparametric MRI and 68Ga-PSMA-PET/MRI - What is the value of quantitative data from multiparametric MRI alone or in conjunction with clinical information? [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-HBED-CC PSMA-PET/CT and multiparametric MRI for gross tumour volume detection in patients with primary prostate cancer based on slice by slice comparison with histopathology. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. [2022]

5. England pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/MRI versus multiparametric MRI in men referred for prostate biopsy: primary tumour localization and interreader agreement. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of PSMA-based 18F-DCFPyL PET/CT and pelvic multiparametric MRI for lesion detection in the pelvis in patients with prostate cancer. [2023]

8. Germany 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Targeted Biopsy in Men High Risk for Prostate Cancer: 68Ga-PSMA PET/CT Versus mpMRI. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT and mpMRI with a Histopathology Gold Standard in the Detection, Intraprostatic Localization, and Determination of Local Extension of Primary Prostate Cancer: Results from a Prospective Single-Center Imaging Trial. [2023]

11. Germany 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. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Comparing the Detection Performance Between Multiparametric Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen PET/CT in Patients With Localized Prostate Cancer: A Systematic Review and Meta-analysis. [2023]