What is the mechanism of action of this treatment?

Prostate cancer treatments often involve advanced imaging techniques like the PSMA PET scan, which uses a radiotracer that binds to the Prostate-Specific Membrane Antigen (PSMA) on prostate cells. This allows for highly precise imaging, aiding in the detection of micrometastatic disease and guiding treatment decisions. Other treatments include hormone therapy, which reduces androgen levels to slow cancer growth, and radiotherapy, which uses high-energy radiation to kill cancer cells. These mechanisms are crucial as they enable personalized treatment plans, improve detection of disease spread, and potentially enhance patient outcomes by targeting cancer more effectively.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as surgery, radiation therapy, hormone therapy, and chemotherapy, have various side effects. Surgery can lead to urinary incontinence and erectile dysfunction. Radiation therapy may cause fatigue, urinary issues, and bowel problems. Hormone therapy often results in hot flashes, reduced libido, and bone thinning. Chemotherapy can cause nausea, hair loss, and increased risk of infections. PSMA PET scans, which use radiotracers for precise imaging, generally have fewer side effects but may include mild reactions at the injection site and rare allergic reactions.

What prior FDA approvals exist?

The FDA has approved several PSMA-targeted therapies for prostate cancer. Ga-68 PSMA-11 and piflufolastat F-18 are approved for PSMA-targeted PET imaging in males with suspected prostate cancer recurrence based on elevated PSA levels. Additionally, lutetium Lu 177 vipivotide tetraxetan has been approved for treating PSMA-positive metastatic castration-resistant prostate cancer. These treatments utilize radiotracers that bind to the Prostate-Specific Membrane Antigen (PSMA), enabling more precise imaging and targeted therapy.

What other types of research exist?

A promising novel alternative to PSMA PET scans for prostate cancer patients is the multifunctional 18F-labelled PET tracer that combines a PSMA inhibitor with a hypoxia-sensitive moiety. This tracer aims to provide better diagnosis by targeting both PSMA and hypoxic regions within tumors, potentially offering enhanced imaging precision.

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Diagnostic Test

PSMA-PET + MRI for Prostate Cancer

Phase 2 & 3

Recruiting

Led By Clinton Bahler, MD

Research Sponsored by Five Eleven Pharma, Inc.

Eligibility Criteria Checklist

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

Must have

Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR ≥3 cores of Gleason 3+4 OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5

Men diagnosed with prostate cancer who choose radical prostatectomy

Must not have

Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, due to physical limitations or claustrophobia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort from lying still during scans and potential anxiety related to claustrophobia in imaging devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer is aggressive based on my biopsy results.

Select...

I am a man with prostate cancer opting for surgery to remove my prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot stay still on a PET or MRI machine due to physical issues or claustrophobia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

IIEF-EF sub scale score

Secondary study objectives

Therapeutic procedure

EPE detection

Erectile dysfunction: ability to achieve erection sufficient for penetration

+5 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 and SOC MRI prior to surgeryExperimental Treatment1 Intervention

Group II: SOC MRI prior to surgeryActive Control1 Intervention

0 / 3Eligibility criteria met

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 often involve advanced imaging techniques like the PSMA PET scan, which uses a radiotracer that binds to the Prostate-Specific Membrane Antigen (PSMA) on prostate cells. This allows for highly precise imaging, aiding in the detection of micrometastatic disease and guiding treatment decisions. Other treatments include hormone therapy, which reduces androgen levels to slow cancer growth, and radiotherapy, which uses high-energy radiation to kill cancer cells. These mechanisms are crucial as they enable personalized treatment plans, improve detection of disease spread, and potentially enhance patient outcomes by targeting cancer more effectively.

Effect of 18F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial.Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective.Current Use of Imaging after Primary Treatment of Prostate Cancer.