asymptomatic hormone-refractory prostate cancer
Conditions
Interventions
Trade Name: Taxotere concentrate and solvent for solution for infusion
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration un
Sponsors
AUO
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a single arm, prospective Phase II trial to test the safety and efficacy of intermittent chemotherapy with docetaxel (Taxotere®) and prednisone in asymptomatic, hormone-refractory prostate cance;Secondary Objective: - Major toxic events (percentage of patients with > G2 toxicity according to CTC AE 3.0) at treatment and re-treatment. - Duration of each treatment holiday (days / weeks). - Time until PSA response measured from day 1 of each treatment and re-treatment sequence respectively - Percentage of patients with PSA and/or measurable disease-progression within or after the first, second, third or any further treatment sequence - Time to progression (TTP) measured from day 1 of the first chemotherapy cycle until the patient goes off protocol because he is defined to be a “non responder” at defined points in the protocol, or due to any other type of progression. ;Primary end point(s): PSA and/or measurable response to initial treatment and re-treatment after each treatment holiday | — |
Countries
Austria
Outcome results
None listed