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Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy (AdRad)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
docetaxel
Sponsored by
Scandinavian Prostate Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Adjuvant treatment, high risk, radical radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jon R Iversen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Docetaxel arm

Control

Arm Description

six of docetaxel every third week + hormonal treatment

hormonal treatment only

Outcomes

Primary Outcome Measures

PSA progression rate
According to RTOG-ASTRO guidelines

Secondary Outcome Measures

PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
PSA doubling measured, FACT-P, detection of metastatic lesions

Full Information

First Posted
April 2, 2008
Last Updated
March 24, 2021
Sponsor
Scandinavian Prostate Cancer Group
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00653848
Brief Title
Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy
Acronym
AdRad
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 Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scandinavian Prostate Cancer Group
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Adjuvant treatment, high risk, radical radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel arm
Arm Type
Experimental
Arm Description
six of docetaxel every third week + hormonal treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
hormonal treatment only
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
LHRH ananlog 9 months
Intervention Description
docetaxel 75 mg/square meter i.v. every third week, six cycles
Primary Outcome Measure Information:
Title
PSA progression rate
Description
According to RTOG-ASTRO guidelines
Time Frame
From randomization to progression
Secondary Outcome Measure Information:
Title
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
Description
PSA doubling measured, FACT-P, detection of metastatic lesions
Time Frame
From randomisation to year 2014

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirkko-Liisa i Kellokumpu-Lehtinen, Prof
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jon R Iversen
City
Oslo
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy

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