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

University Health Network, Toronto

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Pantoprazole

Study type

Interventional

Funder types

Other

Identifiers

12-0388-C (Other Identifier)

PANDORA

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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