What side effects are associated with this type of intervention?

Common treatments for metastatic castration-resistant prostate cancer, such as 225Ac-PSMA-617 and 177Lu-PSMA-617, often result in hematologic toxicities including thrombocytopenia, lymphopenia, anemia, and leukopenia. Xerostomia (dry mouth) is also a frequent side effect. Radium-223, another radiopharmaceutical, can cause bone marrow suppression and gastrointestinal symptoms. These side effects are important considerations when evaluating advanced prostate cancer treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve radiolabeled agents. One notable approval is for lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy targeting PSMA-positive metastatic castration-resistant prostate cancer (CRPC). This treatment has shown significant improvements in progression-free survival and overall survival in clinical trials. Additionally, radium-223 dichloride (Ra-223) is another radiopharmaceutical approved for CRPC with symptomatic bone metastases, which helps to improve survival and manage bone pain. These treatments, like the 89Zr-DFO-huJ591 PET scan, utilize targeted radioactive agents to detect and treat prostate cancer cells.

What other types of research exist?

Promising alternatives to the 89Zr-DFO-huJ591 PET scan for prostate cancer patients include: 1) PSMA PET scans using radiotracers like 68Ga-PSMA-11 or 18F-DCFPyL, which target the Prostate-Specific Membrane Antigen (PSMA) and have shown high sensitivity and specificity for detecting prostate cancer metastases. 2) 18F-Fluciclovine PET scans, which are FDA-approved for detecting recurrent prostate cancer. These alternatives offer advanced imaging capabilities and are increasingly being integrated into clinical practice.

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89Zr-DFO-huJ591 PET Scan for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Michael Morris, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of scan to see if it can better detect prostate cancer that has spread, especially to the bones. The scan uses a special substance to highlight cancer cells in the body. Researchers hope this will improve future cancer treatments.

Who is the study for?

This trial is for adult males over 18 with confirmed prostate cancer at MSKCC, showing disease progression either through scans or rising PSA levels. Participants must have a performance status of 60+ on the Karnofsky scale and be able to consent. Men who've had anaphylactic reactions to J591 or FDG, or those with certain abnormal liver test results are excluded.

What is being tested?

The study tests the safety and accuracy of a new PET scan using an experimental tracer called 89Zr-DFO-huJ591, aimed at detecting metastatic prostate cancer. It compares this new scan's effectiveness against standard imaging techniques like CT, MRI, bone scans, and FDG PET scans.

What are the potential side effects?

Potential side effects may include reactions related to the small amount of radiation from the tracer used in PET scanning. Specific side effects aren't detailed but could also involve typical risks associated with biopsy procedures if one is performed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Disease

the pharmacokinetics (PK) and biodistribution of 89Zr-DFO-huJ591 PET

Secondary study objectives

Positron-Emission Tomography

PSMA and AR expression and AR axis genomic and proteomic pathways on tumor tissue with the 89Zr-DFO-huJ591 PET imaging characteristics

To use 89Zr-DFO-huJ591 PET image guided biopsies as a means for improved sampling of individual lesions of metastatic prostate cancer

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: 89Zr-DFO-huJ591Experimental Treatment1 Intervention

Registered patients will undergo a baseline FDG PET scan up to 14 days before administration of a single dose of the 89Zr-DFO-huJ591 tracer, this scan is considered for research purposes. The exception to the 14-day timeframe is that patients who have already had an FDG PET scan up to 4 weeks prior to registration are not required to repeat the FDG PET scan on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

89Zr-DFO-huJ591

2012

Completed Phase 2

~80

Do I qualify?Apply below to find out

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 specific molecular markers or pathways to inhibit cancer growth and spread. Androgen deprivation therapy (ADT) reduces androgen levels to slow tumor growth. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Radioligand therapy, such as the 89Zr-DFO-huJ591 PET scan, involves using radioactive substances linked to molecules that specifically target prostate cancer cells, like PSMA. This allows for precise imaging and treatment, improving detection and management of metastatic or castration-resistant prostate cancer. These targeted approaches are crucial as they offer more personalized and effective treatment options, potentially leading to better outcomes for patients.

CUB Domain-Containing Protein 1 (CDCP1) Is a Target for Radioligand Therapy in Castration-Resistant Prostate Cancer, including PSMA Null Disease.Targeting prostate-specific membrane antigen for personalized therapies in prostate cancer: morphologic and molecular backgrounds and future promises.Androgen-independent molecular imaging vectors to detect castration-resistant and metastatic prostate cancer.