Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2021-10-21
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants undergoing 177Lu-PSMA-617 treatment
Participants undergoing PSMA targeted radioligand therapy with at least four cycles of treatment planned will undergo the following: SPECT/CTs will be performed 24 hours after the first treatment and after the fourth treatment, a tumor biopsy will be performed prior to the first 177Lu-PSMA radioligand therapy, a blood will be drawn prior to treatment for future research, and an optional tumor biopsy and blood draw for future research, may also be obtained at time of progression.
Single-photon emission computed tomography
Imaging procedure
Blood Draw
Blood draw for future research tests (45-60 mL).
Tumor Biopsy
Guided biopsy of lesion
Interventions
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Single-photon emission computed tomography
Imaging procedure
Blood Draw
Blood draw for future research tests (45-60 mL).
Tumor Biopsy
Guided biopsy of lesion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Patients who are not able to undergo additional study related imaging procedures.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Prostate Cancer Foundation
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Thomas Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Memorial Sloan Kettering
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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19553
Identifier Type: -
Identifier Source: org_study_id
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