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

NCT01748500 | Completed Phase 2 DMC

• 2 other identifiers: PANDORA12-0388-C
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are:

1. 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. 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. 3.To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.

Conditions

Prostate Cancer

Keywords

metastatic

Outcome Measures

Primary Outcomes (1)

• Confirmed PSA response

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

  20 months

Study Arms (1)

Pantoprazole, Docetaxel, Prednisone

EXPERIMENTAL

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Also known as: Pantoprazole sodium

Pantoprazole, Docetaxel, Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CA (1)