What side effects are associated with this type of intervention?

Common treatments for prostate cancer that use radiotracers targeting PSMA, such as [18F]PSMA-1007 PET/CT imaging, can cause side effects including fatigue, dry mouth, nausea, and mild pain at the injection site. More serious but less common side effects may include renal toxicity, bone marrow suppression (pancytopenia), and long-term risks like myelodysplastic syndrome or secondary leukemia. These side effects are generally manageable but should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several PSMA-targeted radiotracers for prostate cancer imaging, including F-18 piflufolastat (F-18 DCFPyL) and Ga-68 PSMA-11. These radiotracers bind to the prostate-specific membrane antigen (PSMA) on prostate cancer cells, allowing for enhanced detection of micrometastatic disease. Additionally, lutetium Lu 177 vipivotide tetraxetan has been approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (CRPC), demonstrating significant improvements in progression-free survival and overall survival in clinical trials.

What other types of research exist?

Promising novel alternatives to [18F]PSMA-1007 PET/CT imaging for prostate cancer patients include: 1) Ga-68 PSMA-11 PET/MRI, which combines the high sensitivity of PSMA-targeted PET with the superior soft tissue contrast of MRI, improving detection rates even at low PSA levels. 2) Lutetium-177-PSMA-617, a theranostic agent that not only images but also treats PSMA-positive metastatic castration-resistant prostate cancer by delivering targeted radiotherapy. 3) Piflufolastat F-18, approved for PSMA-targeted PET imaging in patients with suspected recurrence based on elevated PSA levels, offering an alternative radiotracer with high diagnostic performance.

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PSMA-1007 PET/CT for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by ABX advanced biochemical compounds GmbH

Eligibility Criteria Checklist

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

Must have

Suspicion of recurrence or persistence after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)

Suspicion of recurrence or persistence after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)

Must not have

Being clinically unstable or requiring emergency treatment

Age: less than18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a special scan to see if it can safely and accurately detect returning prostate cancer in patients who have already been treated.

Who is the study for?

Men with a history of prostate cancer treated previously, who now have signs their cancer might be back. They should expect to live at least another 6 months and be able to undergo all study procedures. Men under 18, those unable to have a PET/CT scan, or with allergies to the test drug can't join.

What is being tested?

[18F]PSMA-1007 PET/CT is being tested for its ability to detect recurrent prostate cancer after initial treatment. The trial will assess how well this imaging technique works and monitor any safety issues that arise during the process.

What are the potential side effects?

While specific side effects are not listed for [18F]PSMA-1007, typical PET/CT scans may cause discomfort at the injection site, allergic reactions, or anxiety about enclosed spaces during scanning.

Eligibility Criteria

Inclusion Criteria

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

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My PSA levels are above 0.2 ng/mL after prostate surgery, indicating possible cancer return or persistence.

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My PSA levels have been rising after treatment, indicating possible cancer return.

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I am a man who has been treated for prostate cancer before.

Exclusion Criteria

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

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I am not in need of emergency care and am clinically stable.

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I am under 18 years old.

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I cannot have a PET/CT scan.

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I am not allergic to any components of [18F]PSMA-1007.

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I am willing to have a biopsy if my doctor recommends it.

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I understand the details and risks of the clinical trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]PSMA-1007Experimental Treatment1 Intervention

single intravenous administration of \[18F\]PSMA-1007 for Positron Emission Tomography (PET) scan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]PSMA-1007

2017

N/A

~230

0 / 9Eligibility 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 target the Prostate-Specific Membrane Antigen (PSMA), a protein overexpressed in prostate cancer cells. PSMA-targeted therapies, such as [18F]PSMA-1007 PET/CT imaging, use radiotracers that bind to PSMA, enabling precise detection and localization of cancer cells. This is particularly important for identifying micrometastatic disease and guiding treatment decisions. Other common treatments include hormone therapy, which reduces androgen levels to slow cancer growth; chemotherapy, which uses drugs to kill rapidly dividing cells; and surgery, which physically removes cancerous tissue. These treatments are selected based on the cancer's stage and the patient's overall health, aiming to improve outcomes and quality of life.

A theranostic PSMA ligand for PET imaging and retargeting of T cells expressing the universal chimeric antigen receptor UniCAR.