Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy
Primary Purpose
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Image Guided Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Castration-Resistant Prostate Carcinoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (image-guided biopsy)
Arm Description
Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.
Outcomes
Primary Outcome Measures
Proportion of patients with a successful evaluable biopsy with altered signaling pathways after radioligand therapy (RLT)
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.
Secondary Outcome Measures
Proportion of patients with gene mutation in regulators of replication stress response according to sequencing
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.
Generation of xenografts
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.
Full Information
NCT ID
NCT03596710
First Posted
July 12, 2018
Last Updated
July 22, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03596710
Brief Title
Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy
Official Title
Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Adaptive Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
sponsor withdrew study
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
June 14, 2021 (Anticipated)
Study Completion Date
June 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (image-guided biopsy)
Arm Type
Experimental
Arm Description
Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.
Intervention Type
Procedure
Intervention Name(s)
Image Guided Biopsy
Other Intervention Name(s)
Image-Guided Biopsy, Imaging Guided Biopsy
Intervention Description
Undergo image guided biopsy
Primary Outcome Measure Information:
Title
Proportion of patients with a successful evaluable biopsy with altered signaling pathways after radioligand therapy (RLT)
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Proportion of patients with gene mutation in regulators of replication stress response according to sequencing
Description
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.
Time Frame
Up to 3 years
Title
Generation of xenografts
Description
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.
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Rettig
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy
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