Clinical trial NCT00653848: Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Adjuvant treatment, high risk, radical radiotherapy
Lead sponsor: Scandinavian Prostate Cancer Group
Sponsor class: NETWORK
Collaborators: name: Sanofi
First posted: 2008-04-07
Enrollment: 378
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: PSA progression rate
timeFrame: From randomization to progression
Secondary outcomes:
measure: PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
timeFrame: From randomisation to year 2014
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Jon R Iversen
Study officials:
affiliation: Tampere University Hospital
name: Pirkko-Liisa i Kellokumpu-Lehtinen, Prof
role: PRINCIPAL_INVESTIGATOR
References: