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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03596710
Other study ID # 18-000273
Secondary ID NCI-2018-0142218
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 14, 2018
Est. completion date June 14, 2022

Study information

Verified date July 2018
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 14, 2022
Est. primary completion date June 14, 2021
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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 Design


Intervention

Procedure:
Image Guided Biopsy
Undergo image guided biopsy

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 3 years
Secondary 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. Up to 3 years
Secondary 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. Up to 3 years
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