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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Pantoprazole

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pantoprazole, Docetaxel, Prednisone	Drug: Pantoprazole; Other Names: Pantoprazole sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed PSA response	The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.	20 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: metastatic
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: PANDORA; 12-0388-C (Other Identifier: UHN REB)