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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Pantoprazole
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pantoprazole, Docetaxel, Prednisone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 10, 2012
Last Updated
March 19, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01748500
Brief Title
Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pantoprazole, Docetaxel, Prednisone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Pantoprazole sodium
Primary Outcome Measure Information:
Title
Confirmed PSA response
Description
The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.
Time Frame
20 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada

12. IPD Sharing Statement

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

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