NL-OMON35597RecruitingPhase 3
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. - PSA-ERECT
Scandinavian Prostate Cancer Group0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- 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.
Exclusion Criteria
- •- 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.
Investigators
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