Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy

NCT01224405 | Unknown Phase 3 DMC

• 1 other identifier: EudraCT 2010-019004-24
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 32

Brief 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

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  The primary aim of the study will be the demonstration of non inferiority in terms of overall survival of stopping androgen deprivation therapy (arm B) versus maintenance androgen deprivation therapy (arms A) and intermittent docetaxel therapy (arm AB1) versus continuous docetaxel therapy (arms AB2) up to ten cycles.

  six years

Secondary Outcomes (5)

• Toxicity

  six years

• Progression free survival

  six years

• Quality of life

  six years

• Pain

  six years

• Cost Analysis

  six years

Study Arms (4)

Treatment arm

ACTIVE COMPARATOR

ten docetaxel cycles + maintenance androgen deprivation.

Drug: Docetaxel + LH-RH analogues

suspension arm

EXPERIMENTAL

Ten Docetaxel cycles + stop androgen deprivation therapy

Drug: Docetaxel

intermittent arm

EXPERIMENTAL

Intermittent Docetaxel

Drug: Docetaxel

Continuous arm

ACTIVE COMPARATOR

Continuous Docetaxel

Drug: Continuous Docetaxel

Interventions

Docetaxel + LH-RH analogues DRUG

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.

Treatment arm

Docetaxel DRUG

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.

suspension arm

Continuous Docetaxel DRUG

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.

Continuous arm

Eligibility Criteria

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

You may qualify if:

• age over 18 years,
• histologically documented adenocarcinoma of the prostate,
• written informed consent to the study,
• Castrate resistant metastatic prostate cancer in the presence of castrate levels of testosterone (\<50 ng/ml) and eligible to docetaxel chemotherapy. The condition of castrate resistant prostate cancer is the defined either as the documentation of a new metastasis or PSA increase more than 50% or increase more than 25% from a lower PSA value during previous hormone therapy in case of disease response or stabilization to previous hormone therapy, respectively. Absolute PSA increase should be greater than 5 ng/ml,
• an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy,
• more than 4 weeks since major surgery and fully recovered,
• more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less,
• more than 8 weeks since the last dose of strontium or samarium,
• ECOG Performance Status more than/equal to 2,
• life expectancy \>6 months,
• required initial laboratory values: absolute neutrophil count \> 1500/ul Platelets \> 100,000/ul., Hemoglobin \> 8.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal, Bilirubin less than/equal to upper limit of normal (ULN).
• Appropriate patient compliance

You may not qualify if:

• Patients with increased serum PSA levels with negative bone scan and CT scan.
• Prior systemic chemotherapy for prostate cancer. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy,
• Peripheral neuropathy \>grade 1,
• myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
• patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80,
• poorly controlled diabetes (fasting blood glucose \>250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy,
• previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
• significant neurologic or psychiatric diseases preventing patients to give a valid informed consent,
• brain metastases,
• prisoner status
• because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (32)

Davide Perroni

Saluzzo, Cuneo, Italy

Location

Roberto Faggiuolo

Alba, Italy

Location

Franco Testore

Asti, Italy

Location

Mario Clerico

Biella, Italy

Location

Andrea Martoni

Bologna, Italy

Location

Massimo Aglietta

Candiolo (Torino), Italy

Location

Alberto Muzio

Casale Monferrato, Italy

Location

Mario Botta

Casale Monferrato, Italy

Location

Rodolfo Passalacqua

Cremona, Italy

Location

Marco Merlano

Cuneo, Italy

Location

Luigi Toniolo

Garbagnate Milanese, Italy

Location

Sergio Bretti

Ivrea, Italy

Location

Giovanni Ucci

Lodi, Italy

Location

Pierfranco Conte

Modena, Italy

Location

Carla Sculli

Mondovì, Italy

Location

Oscar Alabiso

Novara, Italy

Location

Bruno Castagneto

Novi Ligure, Italy

Location

Giovanna Succu

Nuoro, Italy

Location

Alfredo Berruti

Orbassano (Torino), Italy

Location

Luigi Dogliotti

Orbassano (Torino), Italy

Location

Luigi Cavanna

Piacenza, Italy

Location

Giorgio Cruciani

Ravenna, Italy

Location

Corrado Boni

Reggio Emilia, Italy

Location

Riccardo Ratti

Sanremo, Italy

Location

Francesco Ferrau

Taormina, Italy

Location

Fausto Roila

Terni, Italy

Location

Carlo Alberto Raucci

Torino, Italy

Location

Guido Vietti Ramus

Torino, Italy

Location

Libero Ciuffreda

Torino, Italy

Location

Gianpiero Fasola

Udine, Italy

Location

Sergio Cozzi

Verbania, Italy

Location

Domenico Amoroso

Viareggio, Italy

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Alfredo Berruti, PHD

  Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy

  STUDY CHAIR

• Bruno Castagneto, MD

  Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) Italy

  STUDY DIRECTOR

• Marcello Tucci, MD

  Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: October 20, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2016
• Last Updated: October 20, 2010

Record last verified: 2010-06

Locations

IT (32)