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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. Identifier: NCT01748500
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : March 23, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Pantoprazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : March 2021
Actual Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Pantoprazole, Docetaxel, Prednisone Drug: Pantoprazole
Other Name: Pantoprazole sodium

Primary Outcome Measures :
  1. Confirmed PSA response [ Time Frame: 20 months ]
    The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01748500

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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT01748500    
Other Study ID Numbers: PANDORA
12-0388-C ( Other Identifier: UHN REB )
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Keywords provided by University Health Network, Toronto:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action