Treatment of Prostate Cancer With Docetaxel + Hormonal Treatment Versus Hormonal Treatment in Patients Treated With Radical Radiotherapy (AdRad)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653848
Recruitment Status : Active, not recruiting
First Posted : April 7, 2008
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
Scandinavian Prostate Cancer Group

April 2, 2008
April 7, 2008
November 7, 2017
May 2007
August 30, 2020   (Final data collection date for primary outcome measure)
PSA progression rate [ Time Frame: From randomization to progression ]
Same as current
Complete list of historical versions of study NCT00653848 on Archive Site
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival [ Time Frame: From randomisation to year 2014 ]
Same as current
Not Provided
Not Provided
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 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: docetaxel
docetaxel 75 mg/square meter i.v. every third week, six cycles
Other Name: LHRH ananlog 9 months
  • Experimental: Docetaxel arm
    six of docetaxel every third week + hormonal treatment
    Intervention: Drug: docetaxel
  • No Intervention: Control
    hormonal treatment only
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
August 30, 2020
August 30, 2020   (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
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
EudraCT 2006-001657-94
Not Provided
Not Provided
Scandinavian Prostate Cancer Group
Scandinavian Prostate Cancer Group
Principal Investigator: Pirkko-Liisa i Kellokumpu-Lehtinen, Prof Tampere University Hospital
Scandinavian Prostate Cancer Group
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP