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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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: 378
Study Start Date: May 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts
Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, Prof +358505951103 Pirkko-liisa.Kellokumpu-Lehtinen@uta.fi
Contact: Claes Ginman, MD +4654655000 Claes.Ginman@liv.se

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

No publications provided

Responsible Party: Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00653848     History of Changes
Other Study ID Numbers: SPCG-13, EudraCT 2006-001657-94
Study First Received: April 2, 2008
Last Updated: June 15, 2010
Health Authority: Finland: Finnish Medicines Agency

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014