Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Thomas Hope, MD

Description

Summary

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

Official Title

Mechanisms of Resistance to PSMA Radioligand Therapy: Radiation Resistance Versus Dose

Details

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.

Keywords

Prostate Cancer Radioligand Therapy Prostatic Neoplasms Single-photon emission computed tomography Blood Draw Tumor Biopsy

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Initiating treatment with Lutetium based PSMA-targeted RLT.
  2. 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.
  3. 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.
  4. Age >=18 years.
  5. Ability to understand and the willingness to sign a written informed consent document.

You CAN'T join if...

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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05435495
Study Type
Observational
Participants
Expecting 125 study participants
Last Updated