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

Scandinavian Prostate Cancer Group

Status and phase

Unknown

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: docetaxel

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00653848

SPCG-13

2006-001657-94 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment

378 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No 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