Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01748500|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2012
Last Update Posted : June 12, 2018
The main objectives of this trial are:
- To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men with metastatic CRPC who have not received prior chemotherapy.
- To evaluate archival prostate cancer tissue of men included in the clinical trial for evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.
- To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Pantoprazole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2018|
|Experimental: Pantoprazole, Docetaxel, Prednisone||
Other Name: Pantoprazole sodium
- Confirmed PSA response [ Time Frame: 20 months ]The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748500
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G2M9|