Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748500
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G2M9|