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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Scandinavian Prostate Cancer Group Identifier:
First received: April 2, 2008
Last updated: October 27, 2016
Last verified: October 2016
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

Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Scandinavian Prostate Cancer Group:

Primary Outcome Measures:
  • PSA progression rate [ Time Frame: From randomization to progression ]

Secondary Outcome Measures:
  • PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival [ Time Frame: From randomisation to year 2014 ]

Enrollment: 378
Study Start Date: May 2007
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel arm
six of docetaxel every third week + hormonal treatment
Drug: docetaxel
docetaxel 75 mg/square meter i.v. every third week, six cycles
Other Name: LHRH ananlog 9 months
No Intervention: Control
hormonal treatment only

Detailed Description:

Primary endpoint:

  • PSA progression rate, ASTRO guidelines.

Secondary endpoints:

  • PSA doubling time after progression
  • Quality of Life (QoL)
  • Safety
  • Metastases free survival
  • Overall survival

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00653848

Jon R Iversen
Oslo, Norway
Sponsors and Collaborators
Scandinavian Prostate Cancer Group
Principal Investigator: Pirkko-Liisa i Kellokumpu-Lehtinen, Prof Tampere University Hospital
  More Information

Responsible Party: Scandinavian Prostate Cancer Group Identifier: NCT00653848     History of Changes
Other Study ID Numbers: SPCG-13
EudraCT 2006-001657-94
Study First Received: April 2, 2008
Last Updated: October 27, 2016

Keywords provided by Scandinavian Prostate Cancer Group:
Adjuvant treatment, intermediate and high risk, radical radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017