Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy
July 22, 2020 updated by: Jonsson Comprehensive Cancer Center
Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Adaptive Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
This trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (RLT).
Tissue sample collected from a biopsy may help determine why response to RLT varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples.
SECONDARY OBJECTIVES:
I. Generation of patient derived xenograft (PDX) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (PSA) response.
II. Sequencing to identify frequently mutated genes such as TP53 and ATM.
OUTLINE:
Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Volunteer patient
- Histologically confirmed prostate cancer
- Enrolled in Lu-PSMA-617 treatment trial (Institutional Review Board [IRB]# 17-000330)
- Based on positron emission tomography (PET)/computed tomography (CT) images: evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
- Platelets > 75,000/ul within 14 days prior to biopsy
- Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy
- Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)
Exclusion Criteria:
- Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Diagnostic (image-guided biopsy)
Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.
|
Undergo image guided biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with a successful evaluable biopsy with altered signaling pathways after radioligand therapy (RLT)
Time Frame: Up to 3 years
|
No statistical power analysis was performed as this is a pilot study.
An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy.
The study will in subsequent studies use the information obtained here to design a more definitive trial.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with gene mutation in regulators of replication stress response according to sequencing
Time Frame: Up to 3 years
|
No statistical power analysis was performed as this is a pilot study.
An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy.
The study will in subsequent studies use the information obtained here to design a more definitive trial.
|
Up to 3 years
|
|
Generation of xenografts
Time Frame: Up to 3 years
|
No statistical power analysis was performed as this is a pilot study.
An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy.
The study will in subsequent studies use the information obtained here to design a more definitive trial.
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 14, 2018
Primary Completion (ANTICIPATED)
June 14, 2021
Study Completion (ANTICIPATED)
June 14, 2022
Study Registration Dates
First Submitted
July 12, 2018
First Submitted That Met QC Criteria
July 12, 2018
First Posted (ACTUAL)
July 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-000273 (OTHER: UCLA / Jonsson Comprehensive Cancer Center)
- NCI-2018-01422 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- P50CA092131 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.