Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy (AdRad)
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|ClinicalTrials.gov Identifier: NCT00653848|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2008
Last Update Posted : March 25, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: docetaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||378 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||August 30, 2023|
|Estimated Study Completion Date :||August 30, 2023|
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 [ Time Frame: From randomization to progression ]According to RTOG-ASTRO guidelines
- PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival [ Time Frame: From randomisation to year 2014 ]PSA doubling measured, FACT-P, detection of metastatic lesions
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653848
|Jon R Iversen|
|Principal Investigator:||Pirkko-Liisa i Kellokumpu-Lehtinen, Prof||Tampere University Hospital|
|Responsible Party:||Scandinavian Prostate Cancer Group|
|Other Study ID Numbers:||
2006-001657-94 ( EudraCT Number )
|First Posted:||April 7, 2008 Key Record Dates|
|Last Update Posted:||March 25, 2021|
|Last Verified:||March 2021|
Adjuvant treatment, high risk, radical radiotherapy
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases
Molecular Mechanisms of Pharmacological Action