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.AdRad”Scandinavian Prostate Cancer Group Trial 13 - AdRad

Conditions: Intermediate or high-risk prostate cancer treated with radical radiotherapy
MedDRA version: 8.1Level: PTClassification code 10060862Term: Prostate cancer

Registration Number: EUCTR2006-001657-94-FI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 924

Inclusion Criteria

1. > 18 and =75 years of age
2. Radical radiotherapy for prostate cancer
3. WHO/ECOG performance status 0 – 1
4. Histologically proven adenocarcinoma of the prostate within 9 months prior to randomisation.
5. One of the following:
T2 with Gleason 7 (4+3) and PSA >10 ng/ml
T2 with Gleason 8-10, any PSA
any T3 tumours.
6. Prior neoadjuvant hormone therapy is mandatory for all patients
7. Adequate haematological-, liver- and kidney function (less than 1.5 x UNL for creatinine, less than 1.5 X UNL for liver laboratory values except bil < UNL).
8.Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. M+
2. N+
3. 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.
4. Previous radiotherapy to pelvic region.
5. Previous chemotherapy within five years.
6. Systemic corticosteroids within 6 months prior to randomisation.
7. Unstable cardiovascular disease within 6 months prior to randomisation.
8. Active untreated infectious disease.
9. Active gastric ulcer.
10. Known hypersensitivity to Polysorbate 80.
11. Other serious illness or medical condition.
12. Symptomatic peripheral neuropathy = CTCAE grade 2.
13. Patients who by altered physical or psychological state not are able to co-operate or participate in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective:<br> time to PSA progression;Secondary Objective: Secondary objectives:<br>PSA doubling time, Quality of Life (QoL), Safety, Metastases free survival, Overall survival.;Primary end point(s): Compare time to PSA progression in intermediate or high-risk prostate cancer patients between chemotherapy+ hormonal treatment versus hormonal treatment alone

Secondary Outcome Measures