Intermittent Treatment with Taxotere and Prednisone in patients with asymptomatic, hormone-refractory prostate cancer: A Multicenter Phase II Trial - TOPAS

Conditions: asymptomatic hormone-refractory prostate cancer

Registration Number: EUCTR2006-005364-65-AT

Lead Sponsor: AUO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

- Histologically proven adenocarcinoma of the prostate
- Hormone refractory prostate cancer with or without metastases after definitive treatment of the primary tumor, either radical prostatectomy or definitive radiotherapy of the prostate, defined as progression under prior hormonal treatment with LH-RH analogues or orchiectomy and anti-androgens, given either together or consecutively
- Irradiation of the tumor-bed allowed
- Progressive disease, defined as PSA progression documented by 2 increased PSA values over a previous reference value or measurable disease progression according to the modRECIST criteria
- PSA at time of study entry > 5 ng/ml (hybritech or equivalent, normal lab upper value 4 ng/ml) within 1 week prior to randomisation and < 40 ng/ml.
- Age =18 years
- WHO Performance status 0-2
- No tumor-related symptoms
- Stable analgesic use is allowed
- Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at least 6 weeks prior to the start of chemotherapy
- Continuation of bisphosphonates allowed
- Castrate level of testosterone (< 0.5 ng/ml). Patients with medical castration with LH-RH analogue must continue LH-RH analogue.
- Adequate haematological functions:
Hb = 10 g/dl; WBC = 3.500 x109/l; ANC = 1,5 x109/l; platelets = 100 x109/l.
- Adequate liver function:
Bilirubin = 1,5 x UNL (upper normal level); ASAT and ALAT = 1,5 x UNL.
- Before patient registration / randomization, written informed consent must be given according to ICH-GCP, and national / local regulations

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

- Evidence of brain metastases.
- Painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionucleides are considered necessary by the treating physician.
- Unequivocal tumor-related symptoms.
- Increasing analgesic use, unstable pain.
- Prior treatment with chemotherapy, bone-seeking radionucleides or radiotherapy involving more than 25% of bone marrow producing area. (Prior use of Estramustine phosphate and/or bisphosphonates are allowed.)
- Active infection or known HIV.
- History of interstitial pneumonitis or pulmonary fibrosis.
- Pre-existing neuropathy (PNP = G1).
- Second primary cancer (except adequately treated superficial cancers e.g. superficial urothelial cancer or in situ carcinomas, skin cancer and melanoma without signs of recurrence in the past 5 years).
- Concurrent treatment with other experimental drugs or anti-cancer drugs (except LH-RH agonist).
- Any condition / concomitant disease not allowing chemotherapy with docetaxel and prednisone from an internal medicine point of view. (Renal insufficiency requiring dialyses; congestive heart failure or uncontrolled angina pectoris; prior myocardial infarction within 6 months of start of chemotherapy; uncontrolled hypertension or arrhythmias; dementia; instable diabetes mellitus, ulceration from diabetes mellitus or other conditions not allowing high dose corticosteroids; effusions in pericardium, pleura or abdomen symptomatic and in need of being punctured.
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule