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Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01748500
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
97.9
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 1, 2013
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pantoprazole, Docetaxel, Prednisone

Drug: Pantoprazole
Other Names:
  • Pantoprazole sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed PSA response [20 months]

      The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Cancer Centre Toronto Ontario Canada M5G2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01748500
    Other Study ID Numbers:
    • PANDORA
    • 12-0388-C
    First Posted:
    Dec 12, 2012
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by University Health Network, Toronto
    metastatic
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Pantoprazole

    Study Results

    No Results Posted as of Mar 23, 2021