Status:
UNKNOWN
Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy
Lead Sponsor:
Scandinavian Prostate Cancer Group
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE3
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 adjuvan...
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00653848
Start Date
May 1 2007
End Date
August 30 2023
Last Update
March 25 2021
Active Locations (1)
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1
Jon R Iversen
Oslo, Norway