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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 : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

December 10, 2012
December 12, 2012
January 3, 2018
January 2013
October 2016   (Final data collection date for primary outcome measure)
Confirmed PSA response [ Time Frame: 20 months ]
The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.
Same as current
Complete list of historical versions of study NCT01748500 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer
Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)

The main objectives of this trial are:

  1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men with metastatic CRPC who have not received prior chemotherapy.
  2. 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.
  3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: Pantoprazole
Other Name: Pantoprazole sodium
Experimental: Pantoprazole, Docetaxel, Prednisone
Intervention: Drug: Pantoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
Same as current
June 2018
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥18yrs
  • ECOG performance status ≤2
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Clinical or radiological evidence of metastatic disease
  • Disease progression while receiving androgen deprivation therapy with an increase in PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1 week apart
  • Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction in serum PSA after this therapy was initiated
  • Baseline serum prostate-specific antigen (PSA)≥10ng/ml
  • Total testosterone <50 ng/dL (<1.7 nmol/L)
  • Adequate hematologic values: neutrophil count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10.0 g/dl
  • Adequate hepatic and renal function: total bilirubin level ≤1.5 x ULN (unless secondary to documented Gilbert's disease); ALT,AST, and creatinine ≤1.5 x ULN
  • Ability to understand and to sign consent for the study

Exclusion Criteria:

  • Prior treatment for prostate cancer with chemotherapy or radioisotopes
  • History of another cancer within the preceding five years (except basal or squamous-cell skin cancer or adequately treated superficial bladder cancer)
  • Known or suspected brain or leptomeningeal metastases
  • Symptomatic peripheral neuropathy of grade 2 or higher
  • Major surgery within 4 weeks of start of trial treatment
  • Radiotherapy to ≥25% of the bone marrow and any radiotherapy within 4 weeks of start of trial treatment
  • Known hypersensitivity to trial treatment or hypersensitivity to any of its components
  • Any concomitant drugs contraindicated for use with the trial treatment
  • Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
  • Any psychological, familial, sociological or other patient related factors that might preclude compliance with the study protocol
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01748500
PANDORA
12-0388-C ( Other Identifier: UHN REB )
Yes
Not Provided
Not Provided
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP