Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy (PON-PC-02)

University of Turin

Status and phase: Unknown; Phase 3

Conditions: Advanced Prostate Cancer

Treatments: Drug: Docetaxel + LH-RH analogues; Drug: Docetaxel; Drug: Continuous Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01224405

EudraCT 2010-019004-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Treatment arm

Active Comparator group

Description:

ten docetaxel cycles + maintenance androgen deprivation.

Treatment:

Drug: Docetaxel + LH-RH analogues

suspension arm

Experimental group

Description:

Ten Docetaxel cycles + stop androgen deprivation therapy

Treatment:

Drug: Docetaxel

Drug: Docetaxel

intermittent arm

Experimental group

Description:

Intermittent Docetaxel

Treatment:

Drug: Docetaxel

Drug: Docetaxel

Continuous arm

Active Comparator group

Description:

Continuous Docetaxel

Treatment:

Drug: Continuous Docetaxel

Drug: Continuous Docetaxel