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Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After 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.
 
ClinicalTrials.gov Identifier: NCT00653848
Recruitment Status : Active, not recruiting
First Posted : April 7, 2008
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Scandinavian Prostate Cancer Group

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2007
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. PSA progression rate [ Time Frame: From randomization to progression ]
    According to RTOG-ASTRO guidelines


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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


Locations
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Norway
Jon R Iversen
Oslo, Norway
Sponsors and Collaborators
Scandinavian Prostate Cancer Group
Sanofi
Investigators
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Principal Investigator: Pirkko-Liisa i Kellokumpu-Lehtinen, Prof Tampere University Hospital
More Information
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Responsible Party: Scandinavian Prostate Cancer Group
ClinicalTrials.gov Identifier: NCT00653848    
Other Study ID Numbers: SPCG-13
2006-001657-94 ( EudraCT Number )
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Keywords provided by Scandinavian Prostate Cancer Group:
Adjuvant treatment, high risk, radical radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
 Prostatic Diseases
Male Urogenital Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action