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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01422 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18-000273 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center | |
| P50CA092131 | U.S. NIH Grant/Contract | View source |
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sponsor withdrew study
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (image-guided biopsy) | Experimental | Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image Guided Biopsy | Procedure | Undergo image guided biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Rettig | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
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| Up to 3 years |
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D061705 | Image-Guided Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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