Treatment of Prostate Cancer With Docetaxel + Hormonal Treatment Versus Hormonal Treatment in Patients Treated With Radical Radiotherapy
This trial is active, not recruiting.
|Sponsor||Scandinavian Prostate Cancer Group|
|Start date||May 2007|
|End date||December 2017|
|Trial size||378 participants|
|Trial identifier||NCT00653848, EudraCT 2006-001657-94, SPCG-13|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
six of docetaxel every third week + hormonal treatment
hormonal treatment only
PSA progression rate
time frame: From randomization to progression
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
time frame: From randomisation to year 2014
Male participants from 18 years up to 75 years old.
- 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
- 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
|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|
Call for more information