An open randomized phase III trial of six cycles of docetaxel versus surveillance after radical prostatectomy in prostate cancer patients with high grade pT3 or margin positive pT2 - AdPro

Phase 1

• Conditions: Men, 18-70 years old, who have had radical prostatectomy due to prostate cancer and with a high grade pT3 or margin positive pT2 tumour may be candidates for the study.C 61.9

• Registration Number: EUCTR2005-002355-40-IS
• Lead Sponsor: Scandinavian prostate cancer group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-30
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

•Men > 18 and =70 years of age.
•WHO/ECOG performance status 0 – 1.
•Histological proven adenocarcinoma of the prostate.
•One of the following:
opT2 with Gleason score 4+3 or 8–10 and positive margins in the radical prostatectomy specimen or
oany pT3a tumour with Gleason score 4+3 or higher or
opT3b tumour with any Gleason score 7 or higher
•If pre-operative PSA ? 10.0 ng/ml, lymph node dissection should be performed.
•Post-operative PSA < 0.5 ng/ml.
•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, total serum bilirubin = 1 x ULN)
•Negative bone scan prior to trial start.
•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

*M+ (Positive bone scan indicating spread of tumour).
*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 hormonal manipulation (e.g. LHRH analogues and/or antiandrogens) affecting prostate cancer cells.
*Previous radiotherapy to pelvic region.
*Previous chemotherapy.
*Systemic corticosteroids within 6 months prior to randomisation.
*Unstable cardiovascular disease within 6 months prior to randomisation.
*Active untreated infectious disease.
*Active gastric ulcer.
*Known hypersensitivity to Polysorbate 80.
*Other serious illness or medical condition.
*Symptomatic peripheral neuropathy = CTCAE grade 2.
*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