What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as Proton Beam Therapy (PBT) and lutetium Lu 177 vipivotide tetraxetan, have specific side effects. PBT is primarily associated with adverse effects like urinary and rectal toxicity. Lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, commonly causes myelosuppression, nephrotoxicity, and salivary gland toxicity (pain, swelling, and dry mouth). Additionally, PSMA PET imaging, which targets PSMA to improve visualization of prostate cancer, can lead to changes in management plans but does not inherently have direct side effects. However, the treatments guided by these imaging techniques may have their own side effects, such as those mentioned above.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that target PSMA to improve visualization and treatment. One notable approval is for lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy that targets PSMA, which has shown significant improvements in radiographic progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC). Additionally, [18F]DCFPyL PET/CT has been approved for imaging prostate cancer, enhancing staging and response assessment by targeting PSMA. These advancements highlight the therapeutic and diagnostic potential of PSMA-targeted approaches in prostate cancer management.

What other types of research exist?

Promising novel alternatives to PSMA PET imaging for prostate cancer patients include multiparametric MRI (mpMRI) and next-generation imaging techniques such as integrated PET/CT or PET/MRI using radiotracers more sensitive than fluorodeoxyglucose. These methods have shown improved sensitivity in detecting disease spread at lower PSA levels and can be particularly useful in guiding treatment decisions.

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Diagnostic Test

PSMA PET Scan for Prostate Cancer

Phase 2

Waitlist Available

Led By William Aronson, MD

Research Sponsored by VA Greater Los Angeles Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site from the radiotracer (18F-DCFPyl), discomfort during imaging procedures, and possible allergic reactions, although specific side effects will depend on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detection of Clinically Significant Prostate Cancer

Secondary study objectives

Adverse Events Associated with 18F- DCFPyl

Correlation of AI Measures with Aggressiveness of Prostate Cancer

Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PSMA PET+mpMRIExperimental Treatment2 Interventions

PSMA PET+mpMRI guided prostate biopsy

Group II: mpMRI onlyActive Control1 Intervention

mpMRI only guided prostate biopsy

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments targeting prostate-specific membrane antigen (PSMA) work by binding to the PSMA protein, which is overexpressed on prostate cancer cells. This allows for precise imaging and targeted therapy. For example, PSMA PET imaging uses radiotracers that bind to PSMA, improving the detection of cancerous cells. Similarly, treatments like Lutetium-177-PSMA-617 deliver targeted radiation to PSMA-expressing cells, minimizing damage to surrounding healthy tissue. Understanding these mechanisms is crucial for patients as it highlights the precision and potential effectiveness of these treatments, leading to better-informed decisions and potentially improved outcomes.

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