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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: docetaxel

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 Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Jon R Iversen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: LHRH ananlog 9 months
No Intervention: Control; hormonal treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA progression rate	According to RTOG-ASTRO guidelines	From randomization to progression

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival	PSA doubling measured, FACT-P, detection of metastatic lesions	From randomisation to year 2014

Collaborators and Investigators

• Sponsor: Scandinavian Prostate Cancer Group
• Collaborators: Sanofi
• Investigators: Principal Investigator: Pirkko-Liisa i Kellokumpu-Lehtinen, Prof, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: April 2, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Adjuvant treatment, high risk, radical radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: SPCG-13; 2006-001657-94 (EudraCT Number)