A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.
- Conditions
- Prostate cancerprostate carcinoma1003858810036958
- Registration Number
- NL-OMON35597
- Lead Sponsor
- Scandinavian Prostate Cancer Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
- Men > 18 and <=80 years of age.
- WHO/ECOG performance status 0 - 1.
- Histological proven adenocarcinoma of the prostate.
- Patients who are planned to receive antiandrogen (bicalutamide 150 mg x 1) treatment,
· After Curative treatment
o Prostatectomy: PSA > 10 OR PSA DT < 12 months and PSA > 0.5 (PSA
doubling time calculation must start at a minimum value of > 0.5)
o Radiation: PSA > +2.0 above nadir and PSA >10 OR PSA DT < 12 months
and PSA > 0.5. (PSA bouncing after radiotherapy should be excluded
according to the local traditions, and PSA doubling time calculation must start
at a minimum value of > 0.5)
· In locally advanced (or local not suitable for curative therapy) prostate
cancer patients, PSA < 100 is required before inclusion AND one of the following
o PSA DT < 12 months or
o PSA >20 or
o Gleason score 8-10,
- Previous hormonal therapy in conjunction with radiotherapy is allowed, provided
that the total duration of therapy does not exceed 12 months and has to be
stopped > 12 months ago.
- Testosterone value > 5 nmol/l
- Adequate haematological-, liver- and kidney function.
- Negative bone scan performed no more than 3 months prior to randomisation.
- Additional CT or ultrasound of thorax, abdomen and/or pelvis is optional
- Written informed consent.
- Positive Bone scan.
- Any distant metastasis detected by CT or ultrasound.
- 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 5 years.
- Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad.
- 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.
- Symptomatic peripheral neuropathy >= CTCAE grade 2.
- Patients who by altered physical or psychological state not are able to co-operate
or participate in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate and compare progression free survival (PFS) between the two<br /><br>treatment arms.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate and compare<br /><br>· Metastasis free survival<br /><br>· Cancer specific survival<br /><br>· Overall survival<br /><br>· Quality of Life (QoL)<br /><br>· PSA doubling time after progression</p><br>