| April 2, 2008 |
| July 21, 2008 |
| May 2007 |
| December 2014 (final data collection date for primary outcome measure) |
| PSA progression rate [ Time Frame: From randomization to progression ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00653848 on ClinicalTrials.gov Archive Site |
| PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival [ Time Frame: From randomisation to year 2014 ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Treatment of Prostate Cancer With Docetaxel + Hormonal Treatment Versus Hormonal Treatment in Patients Treated With Radical Radiotherapy |
| 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 |
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 |
Primary endpoint:
- PSA progression rate, ASTRO guidelines.
Secondary endpoints:
- PSA doubling time after progression
- Quality of Life (QoL)
- Safety
- Metastases free survival
- Overall survival
|
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Prostate Cancer |
| Drug: docetaxel |
- Experimental: six of docetaxel every third week + hormonal treatment
- No Intervention: hormonal treatment only
|
| |
| |
| Recruiting |
| 924 |
| December 2014 |
| December 2014 (final data collection date for primary outcome measure) |
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
|
| Male |
| 18 Years to 75 Years |
| No |
|
|
| Norway |
| |
| NCT00653848 |
| Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital |
| SPCG-13, EudraCT 2006-001657-94 |
| Scandinavian Prostate Cancer Group |
| Sanofi-Aventis |
| Principal Investigator: |
Pirkko-Liisa i Kellokumpu-Lehtinen, Prof |
Tampere University Hospital |
|
|
| Scandinavian Prostate Cancer Group |
| April 2008 |