Prostate Cancer Clinical Trial
— SensiCabOfficial title:
Randomized Phase III Trial Comparing Cabazitaxel Combination Hormone Therapy to Hormone Therapy Alone in Metastatic Prostate Cancer or High Risk Disease
Verified date | May 2016 |
Source | Örebro University, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
This clinical trial is designed on the basis of an unmet clinical need, as well as other
factors including: 1) the ability to identify subjects at high risk of dying early from
their disease, 2) the fact that hormonal therapy has already been shown to improve survival
when applied early in the natural history, 3) the availability of chemotherapy such as
cabazitaxel that can improve survival in subjects with advanced disease and 4) that
chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time
to progression.
It is the investigators hypothesis that a more appropriate group of patients who may benefit
from the curative potential of systemic chemo-hormonal modality is that with minimal, but
detectable disease who have a high probability of developing metastatic disease, clinical
symptoms and eventually death from prostate cancer in a defined time frame. The
investigators hypothesize further that the approach is likely to be more effective at a time
of minimal tumour burden, resulting in minimization of the overall burden of therapy and
better quality of life while on treatment.
This trial will determine whether any benefit is gained by adding chemotherapy before
hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or
high risk disease.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | November 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological or cytological confirmed prostate adenocarcinoma Metastatic PC (Prostate cancer) with measurable or evaluable disease or High risk PC (PSA > 100) or Node positive disease (N+) - No prior treatment for prostate cancer (including bisfosfonate) - Age above 18 years - ECOG 0- 2 - Estimated survival > 3 months - WBC 2000 / mm 3, neutrophils =1500 / mm 3, platelets 100,000 / mm 3 - Satisfactory liver function: bilirubin, transaminases = 1.5 times the upper limit of normal. - Satisfactory renal function. Serum creatinine <1.5 x ULN (150 mmol/l). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted in the study. https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr - Patient information and signature of informed consent Exclusion Criteria: - Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA) - Severe peripheral neuropathy - Active infection or other serious underlying pathology that could prevent patients from receiving treatment - History of cancer within 5 years before inclusion in the study other than basal cell or squamous cell skin cancer adequately treated - Brain metastases, uncontrolled symptomatic or asymptomatic - Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization. - Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B) - Systemic treatment with high dose steroids - Any severe acute or chronic medical condition which would impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures. - History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | University Hospital of Örebro | Örebro |
Lead Sponsor | Collaborator |
---|---|
Örebro University, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | From date of randomization until date of death from any cause, assessed up to 7 years. | No | |
Secondary | Progression free survival | Ct and bonescan at three and six months and then at progession. PSA assesments every three moths during the first year and then every six months until progression. | From date of randomization until progression, assessed up to 3 years. | No |
Secondary | PSA response | Assements every three months during the first year. Then every six months until progression. Then after progression every 12 months. | From date of randomization up to 7 years. | No |
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