Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy

Phase 3

• Conditions: Advanced Prostate Cancer
• Interventions: Drug: Docetaxel + LH-RH analogues; Drug: Continuous Docetaxel; Drug: Docetaxel

• Registration Number: NCT01224405
• Lead Sponsor: University of Turin, Italy

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

Detailed Description

The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III This study design that includes a double randomizzzazione aims generally demonstrating non-inferiority in terms of survival of the suspension dell'ormonoterapia versus the maintenance and / or administration of intermittent versus continuous administration of chemotherapy in patients with prostate cancer resistant to chemical castration I started to line chemotherapy with Docetaxel.

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-06
• Primary Completion: 2010-08
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

1. age over 18 years,
2. histologically documented adenocarcinoma of the prostate,
3. written informed consent to the study,
4. 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,
5. an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy,
6. more than 4 weeks since major surgery and fully recovered,
7. more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less,
8. more than 8 weeks since the last dose of strontium or samarium,
9. ECOG Performance Status more than/equal to 2,
10. life expectancy >6 months,
11. 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).
12. Appropriate patient compliance

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Exclusion Criteria

1. Patients with increased serum PSA levels with negative bone scan and CT scan.

2. 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,

3. Peripheral neuropathy >grade 1,

4. 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,

5. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80,

6. poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy,

7. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,

8. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent,

9. brain metastases,

10. prisoner status

11. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Docetaxel + LH-RH analogues	ten docetaxel cycles + maintenance androgen deprivation.
Continuous arm	Continuous Docetaxel	Continuous Docetaxel
suspension arm	Docetaxel	Ten Docetaxel cycles + stop androgen deprivation therapy
intermittent arm	Docetaxel	Intermittent Docetaxel

Primary Outcome Measures

Name	Time	Method
overall survival	six years	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.

Secondary Outcome Measures

Name	Time	Method
Toxicity	six years	Toxicity graded according to NCI Criteria
Progression free survival	six years	Progression free survival measured according to Prostate Cancer Clinical Trials Working Group
Quality of life	six years	Quality of life evaluated according to FACT-P questionnaire
Pain	six years	Pain response evaluated by Mc-Gill Pain Questionnaire
Cost Analysis	six years	A cost minimization analysis will be performed in order to find if there is a treatment strategy that may achieve the same outcome for least cost. The analysis will focus on the direct medical costs of each treatment, collected at patient level.

Trial Locations

Locations (32)

Davide Perroni; 🇮🇹 Saluzzo, Cuneo, Italy

Carlo Alberto Raucci; 🇮🇹 Torino, Italy

Oscar Alabiso; 🇮🇹 Novara, Italy

Giorgio Cruciani; 🇮🇹 Ravenna, Italy

Corrado Boni; 🇮🇹 Reggio Emilia, Italy

Alfredo Berruti; 🇮🇹 Orbassano (Torino), Italy

Luigi Dogliotti; 🇮🇹 Orbassano (Torino), Italy

Sergio Cozzi; 🇮🇹 Verbania, Italy

Luigi Cavanna; 🇮🇹 Piacenza, Italy

Carla Sculli; 🇮🇹 Mondovì, Italy

Bruno Castagneto; 🇮🇹 Novi Ligure, Italy

Riccardo Ratti; 🇮🇹 Sanremo, Italy

Giovanna Succu; 🇮🇹 Nuoro, Italy

Guido Vietti Ramus; 🇮🇹 Torino, Italy

Domenico Amoroso; 🇮🇹 Viareggio, Italy

Francesco Ferrau; 🇮🇹 Taormina, Italy

Libero Ciuffreda; 🇮🇹 Torino, Italy

Fausto Roila; 🇮🇹 Terni, Italy

Massimo Aglietta; 🇮🇹 Candiolo (Torino), Italy

Marco Merlano; 🇮🇹 Cuneo, Italy

Franco Testore; 🇮🇹 Asti, Italy

Mario Clerico; 🇮🇹 Biella, Italy

Alberto Muzio; 🇮🇹 Casale Monferrato, Italy

Andrea Martoni; 🇮🇹 Bologna, Italy

Rodolfo Passalacqua; 🇮🇹 Cremona, Italy

Roberto Faggiuolo; 🇮🇹 Alba, Italy

Mario Botta; 🇮🇹 Casale Monferrato, Italy

Luigi Toniolo; 🇮🇹 Garbagnate Milanese, Italy

Giovanni Ucci; 🇮🇹 Lodi, Italy

Sergio Bretti; 🇮🇹 Ivrea, Italy

Pierfranco Conte; 🇮🇹 Modena, Italy

Gianpiero Fasola; 🇮🇹 Udine, Italy