Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy

NCT ID: NCT00653848

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2023-08-30

Brief Summary

As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance

Detailed Description

Primary endpoint:

• PSA progression rate, ASTRO guidelines.

Secondary endpoints:

• PSA doubling time after progression
• Quality of Life (QoL)
• Safety
• Metastases free survival
• Overall survival

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel arm

six of docetaxel every third week + hormonal treatment

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

docetaxel 75 mg/square meter i.v. every third week, six cycles

Control

hormonal treatment only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

docetaxel

docetaxel 75 mg/square meter i.v. every third week, six cycles

Intervention Type: DRUG

Other Intervention Names

LHRH ananlog 9 months

Eligibility Criteria

Inclusion Criteria

• Men > 18 and ≤75 years of age.
• WHO/ECOG performance status 0 - 1.
• Histological proven adenocarcinoma of the prostate within 12 months prior to randomisation
• One of the following:

• T2 with Gleason score 7(4+3 ) and PSA >10 ng/ml to < 70 ng/ml
• T2 with Gleason 8-10, any PSA < 70 ng/ml
• any T3 tumour
• Prior neoadjuvant hormone therapy is mandatory for all patients
• Adequate haematological-, liver- and kidney function. (Hemoglobin > 110 g/l, neutrophils > 1.5 x 109/ l, platelets > 150 x 109/ l, ASAT and ALAT < 1.5 x ULN, ALP < 1.5 x ULN, creatinine < 1.5 x ULN)
• Written informed consent

Exclusion Criteria

• M+
• N+ clinical or pathological
• Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years.
• Previous radiotherapy to the pelvic region.
• Previous chemotherapy within 5 years.
• Systemic corticosteroids within 6 months prior to randomisation.
• Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
• Active untreated infectious disease, including tuberculosis, MRSA.
• Active gastric ulcer.
• Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
• Other serious illness or medical condition

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Scandinavian Prostate Cancer Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pirkko-Liisa i Kellokumpu-Lehtinen, Prof

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Jon R Iversen

Oslo, , Norway

Countries

Norway

Other Identifiers

2006-001657-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPCG-13

Identifier Type: -

Identifier Source: org_study_id