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Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy

NCT01224405 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2010-10-20

No results posted yet for this study

Summary

The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III

Conditions

Interventions

DRUG

Docetaxel + LH-RH analogues

Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily. In patients randomised to arms A up to 10 cycles of docetaxel will be planned in association to maintenance of LH-RH analogues administration.

DRUG

Docetaxel

Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily. In patients randomised to arms B up to 10 cycles of docetaxel will be planned, in association to stopping LH-RH analogues.

DRUG

Docetaxel

Patients randomised in the arms AB1 (intermittent docetaxel) will suspend treatment after at least 4 cycles if their PSA level will be reduced \>50%. Docetaxel treatment will be resumed when the serum PSA will rise by \>50% from the lowest PSA level recorded and will be \>10 ng/mL or when there will be other evidence of disease progression. PSA progression must to be confirmed with a second assessment after 2 weeks before deciding to resume docetaxel administration.

DRUG

Continuous Docetaxel

Patients randomised in the arms AB2 (continuous docetaxel) will continue treatment up to ten cycles after even if their PSA level at 4 cycles will be reduced \>50% or will reach a level \<4 ng/mL.

DRUG

Continuous Docetaxel

Patients randomised in the arms AB1(intermittent docetaxel) will continue treatment up to ten cycles even if their PSA level after 4 cycles will be reduced \>50% or will reach a level \<4 ng/mL.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Alfredo Berruti, PHD · Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy

  • Bruno Castagneto, MD · Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) Italy

  • Marcello Tucci, MD · Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-08-31
Completion
2016-04-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01224405 on ClinicalTrials.gov