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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2008 by Scandinavian Prostate Cancer Group
Sponsor:
Collaborator:
Sanofi
Information provided by:
Scandinavian Prostate Cancer Group
ClinicalTrials.gov Identifier:
NCT00653848
First received: April 2, 2008
Last updated: June 15, 2010
Last verified: April 2008

April 2, 2008
June 15, 2010
May 2007
December 2017   (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
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
378
December 2017
December 2017   (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
Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, Prof +358505951103 Pirkko-liisa.Kellokumpu-Lehtinen@uta.fi
Contact: Claes Ginman, MD +4654655000 Claes.Ginman@liv.se
Norway
 
NCT00653848
SPCG-13, EudraCT 2006-001657-94
Yes
Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital
Scandinavian Prostate Cancer Group
Sanofi
Principal Investigator: Pirkko-Liisa i Kellokumpu-Lehtinen, Prof Tampere University Hospital
Scandinavian Prostate Cancer Group
April 2008

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