Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC
NCT number | NCT03176381 |
Other study ID # | mCRPC-PA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2017 |
Est. completion date | November 1, 2023 |
Verified date | November 2023 |
Source | Tianjin Medical University Second Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the HOXB3 (an alternative factor of WNT signaling pathway), FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC (unpublished data). Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA.
Status | Completed |
Enrollment | 110 |
Est. completion date | November 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Participants who have given consent form; 2. Patients with a confirmed diagnosis of mCRPC according to EAU 2017 guideline; 3. Serum testosterone must reach castration level: <50 ng per deciliter; 4. Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment. Exclusion Criteria: 1. Participants who are allergic to contrast medium; 2. Patients were excluded if they planned to receive additional concurrent anticancer therapies; 3. Patients doesn't sign an informed consent form. |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical Unversity Second Hospital | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Second Hospital | Affiliated Hospital of Hebei University, Beijing Chao Yang Hospital, The Second Hospital of Hebei Medical University, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University General Hospital |
China,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PSA response rates | PSA response rates between FKBP5(protein)-positive and FKBP5(protein)-negative (including YAP1-positive and NTS-positive) patients; PSA response rates between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA). | 2 YEARS | |
Secondary | PSA progression-free survival (pPFS) | pPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; pPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA). | 3 YEARS | |
Secondary | clinical or radiographic progression-free survival (cPFS) | cPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; cPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA). | 3 YEARS | |
Secondary | overall survival (OS) | OS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; OS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA). | 3 YEARS |
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