Prostate Cancer Clinical Trial

Mechanisms of Resistance to PSMA Radioligand Therapy

Summary

This is a multicenter, correlative study to existing Lutetium based prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) trials and uses.

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Full Description

PRIMARY OBJECTIVES:

I. To determine the relationship between whole body tumor absorbed dose and response Lutetium based prostate-specific membrane antigen-targeted radioligand therapy (177Lu-PSMA-RLT).

II. To determine the relationship between Post-Operative Radiation Therapy Outcomes Score (PORTOS) score and response to 177Lu-PSMA-RLT.

III. To determine the relative importance of radiation dose (whole body tumor absorbed dose) and radiation sensitivity (PORTOS score) as a marker of response to 177Lu-PSMA-RLT.

EXPLORATORY OBJECTIVES:

I. To develop novel signature of radiation sensitivity.

II. To evaluate tumor biopsies to understand mechanisms of resistance.

III. To understand utility of post-cycle 4 single-photon emission computed tomography (SPECT/CT) to evaluate treatment response.

Study participants will undergo a biopsy and blood draw prior to the initiation of planned therapy, as well as SPECT/CT imaging performed after the first and fourth treatments. One SPECT/CT scan will be performed 24 (+/- 6) after the first treatment, and after the fourth treatment, a 24 +/- 6-hour post-treatment SPECT/CT will be performed. Additionally, study participants may choose to undergo optional biopsy and blood draw at time of progression.

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Eligibility Criteria

Inclusion Criteria:

Initiating treatment with Lutetium based PSMA-targeted RLT.
Participants must have a PSMA-avid lesion that is accessible to biopsy. Biopsy of newly emerging radiographic metastases is desired and preferable to the biopsy of previously existing lesions whenever possible. Newly emerging lesions are defined as those that are absent on a previous scan, or those demonstrating unequivocal progression since initiation of the last treatment. Biopsies will be performed according to local institutional standards.
Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for at least five days prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is approval by the interventional radiologist or the PI.
Age >=18 years.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with significant congenital or acquired bleeding disorders (eg von Wildebrand's disease, acquired bleeding factor inhibitors).
Patients who are not able to undergo additional study related imaging procedures.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

125

Study ID:

NCT05435495

Recruitment Status:

Recruiting

Sponsor:

University of California, San Francisco

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There are 3 Locations for this study

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University of California, Los Angeles
Los Angeles California, 90095, United States More Info
Johannes Czernin, MD
Principal Investigator
Matthew Rettig, MD
Principal Investigator
University of California, San Francisco
San Francisco California, 94143, United States More Info
Maya Aslam
Contact
415-514-8987
[email protected]
Thomas Hope, MD
Principal Investigator
Memorial Sloan Kettering
New York New York, 10065, United States More Info
Lisa Bodei, MD
Principal Investigator
Michael Morris, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

125

Study ID:

NCT05435495

Recruitment Status:

Recruiting

Sponsor:


University of California, San Francisco

How clear is this clinincal trial information?

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