Treatment of Prostate Cancer With Docetaxel + Hormonal Treatment Versus Hormonal Treatment in Patients Treated With Radical Radiotherapy (AdRad)
Verified April 2008 by Scandinavian Prostate Cancer Group
Information provided by:
Scandinavian Prostate Cancer Group
First received: April 2, 2008
Last updated: June 15, 2010
Last verified: April 2008
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
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- PSA progression rate [ Time Frame: From randomization to progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2017 (Final data collection date for primary outcome measure)
Experimental: Docetaxel arm
six of docetaxel every third week + hormonal treatment
docetaxel 75 mg/square meter i.v. every third week, six cycles
Other Name: LHRH ananlog 9 months
No Intervention: Control
hormonal treatment only
- PSA progression rate, ASTRO guidelines.
- PSA doubling time after progression
- Quality of Life (QoL)
- Metastases free survival
- Overall survival
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653848
|Jon R Iversen
|Oslo, Norway |
|Contact: Jon R Iversen |
Scandinavian Prostate Cancer Group
||Pirkko-Liisa i Kellokumpu-Lehtinen, Prof
||Tampere University Hospital
No publications provided
||Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital
History of Changes
|Other Study ID Numbers:
||SPCG-13, EudraCT 2006-001657-94
|Study First Received:
||April 2, 2008
||June 15, 2010
||Finland: Finnish Medicines Agency
Keywords provided by Scandinavian Prostate Cancer Group:
Adjuvant treatment, intermediate and high risk, radical radiotherapy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
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