The usual approach for most patients who are not in a study is treatment with docetaxel. This study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach? This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.
If taking part in this study, the patient will either get docetaxel, or carboplatin in addition to docetaxel. In both cases, the cancer will be monitored by CT scans and bone scans every 9 weeks, and blood tests every 3 weeks. Study treatments, scans, and tests will continue until the disease gets worse. After finishing study treatment, even if treatment is stopped before the disease gets worse, the study doctor will continue to follow patients condition, watch for side effects and keep track of the health of the patient. If treatment is stopped before the disease got worse, patients will be asked to continue getting CT scans and bone scans every 9 weeks, and blood tests every 3 weeks, until the disease worsens. If the disease gets worse while receiving treatment, or after treatment is stopped, the patient will be contacted by phone every 3 months for the rest of their life to monitor their status. Patients may be seen more often if the study doctor thinks it is necessary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
75mg/m2 q21 days
AUC5 q21 days
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
RECRUITINGCross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGBCCA - Vancouver
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGWilliam Osler Health System
Brampton, Ontario, Canada
RECRUITINGWaterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada
RECRUITINGLondon Health Sciences Centre Research Inc.
London, Ontario, Canada
RECRUITINGOttawa Hospital Research Institute
Ottawa, Ontario, Canada
RECRUITINGOdette Cancer Centre
Toronto, Ontario, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITINGCHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
RECRUITING...and 4 more locations
Overall Survival
Time frame: 5.25 years
To compare the two treatment arms with respect to PSA response
Defined as a reduction in PSA from baseline by 50%
Time frame: 5.25 years
To compare the two treatment arms with respect to progression free survival
as defined by PCWG3 and RECIST 1.1
Time frame: 5.25 years
To compare the two treatment arms with respect to time to next systemic therapy
Time frame: 5.25 years
To compare the two treatment arms with respect to time to number and severity of adverse events
Utilizing CTCAE version 5.0
Time frame: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-P questionnaire
Time frame: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-Taxane questionnaire
Time frame: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by BPI-SF questionnaire
Time frame: 5.25 years
Economic Evaluation of healthcare utilization
Health system resources will be identified as, but not limited to, clinic visits, treatments (radiation, surgery, medication), physician encounters, hospitalizations related to treatment and complications, emergent visits and diagnostics.
Time frame: 5.25 years
Economic Evaluation of health utilities measured by Eq-5D-5L
Time frame: 5.25 years
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