Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment docetaxel
Phase phase 3
Sponsor Scandinavian Prostate Cancer Group
Collaborator Sanofi
Start date May 2007
End date December 2017
Trial size 378 participants
Trial identifier NCT00653848, EudraCT 2006-001657-94, SPCG-13

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
six of docetaxel every third week + hormonal treatment
docetaxel LHRH ananlog 9 months
docetaxel 75 mg/square meter i.v. every third week, six cycles
(No Intervention)
hormonal treatment only

Primary Outcomes

Measure
PSA progression rate
time frame: From randomization to progression

Secondary Outcomes

Measure
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
time frame: From randomisation to year 2014

Eligibility Criteria

Male participants from 18 years up to 75 years old.

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

Additional Information

Official title Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-risk Prostate Cancer Treated With Radical Radiotherapy
Principal investigator Pirkko-Liisa i Kellokumpu-Lehtinen, Prof
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Scandinavian Prostate Cancer Group.