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

Phase 3

• Conditions: Prostate Cancer
• Interventions: Drug: docetaxel

• Registration Number: NCT00653848
• Lead Sponsor: Scandinavian Prostate Cancer Group

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

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 378

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel arm	docetaxel	six of docetaxel every third week + hormonal treatment

Primary Outcome Measures

Name	Time	Method
PSA progression rate	From randomization to progression	According to RTOG-ASTRO guidelines

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jon R Iversen; 🇳🇴 Oslo, Norway