Mechanisms of Resistance to PSMA Radioligand Therapy
Mechanisms of Resistance to PSMA Radioligand Therapy: Radiation Resistance Versus Dose
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies, CT scans, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To evaluate tumor biopsies to understand mechanisms of resistance."
- "To understand utility of post-cycle 4 single-photon emission computed tomography (SPECT/CT) to evaluate treatment response."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at why a lutetium-based treatment that targets PSMA may stop working. PSMA is a protein targeted by this radiation treatment. The study is for adults starting this treatment who have a tumor spot that can be sampled.
This is a multicenter, correlative study to existing Lutetium based prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) trials and uses.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are starting lutetium-based radiation treatment that targets PSMA.
- You have a tumor spot that takes up the PSMA-targeted substance and can be reached for a biopsy (taking a small tissue sample). A new or clearly growing spot is preferred when possible.
- If you take warfarin, aspirin, or another blood thinner, you must be able to safely stop it for at least 5 days before the biopsy. An approved switch to a different blood thinner may be allowed.
- You are at least 18 years old.
- You can understand the study and are willing to sign a written consent form.
Who can't join
- You have a serious bleeding disorder, whether you were born with it or developed it later.
- You cannot have the extra scans needed for the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Study sites (3)
CA
- University of California, Los Angeles · Los Angeles, CA 90095Johannes Czernin, MD · Principal investigatorMatthew Rettig, MD · Principal investigatorMore trials in Los Angeles
- University of California, San Francisco · San Francisco, CA 94143Maya Aslam · Study contact · 415-514-8987 · Maya.Aslam@ucsf.edu · Study contact · 877-827-3222 · cancertrials@ucsf.eduThomas Hope, MD · Principal investigatorMore trials in San Francisco
NY
- Memorial Sloan Kettering · New York, NY 10065Lisa Bodei, MD · Principal investigatorMichael Morris, MD · Principal investigatorMore trials in New York