Prostate Cancer Clinical Trial
Official title:
Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy
Verified date | May 2023 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if a combination of neoadjuvant dutasteride and bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male sex - Diagnosis of prostate adenocarcinoma as confirmed by prostate biopsy - Prostate cancer with stage T1a, T1b T2a or T2b Nx Mx as determined by clinical examination - Gleason score of 6 or less or 7 (3+4)* * If Gleason score is 7(3+4) patient must have less than 30% of biopsied tissue positive - Serum PSA of = 15ng/ml during the month before study entry - Prostate volume = 45cc - Normal serum testosterone during the month before study entry - Availability for treatment and follow-up visits - Having signed required consent form before study entry Exclusion Criteria: - Abnormal Liver Function tests (>2x normal AST or ALT and/or >1.5x normal bilirubin) - Prostate volume less than 50 cc - History of hormonal treatment including any of the above: LHRH agonists, antiandrogens during the year before study entry - Use of a 5 alpha reductase inhibitor for more than one month during the year prior to study entry - History of pelvic irradiation - History of past chemotherapy - History of TURP - History of past treatment for prostate cancer - Known hypersensitivity to Dutasteride or Bicalutamide - Co-morbid disease possibly compromising treatment compliance - History of DVT or pulmonary embolism - Anticoagulation with coumarin - Inability to give consent |
Country | Name | City | State |
---|---|---|---|
Canada | CHUQ- Hotel-Dieu de Quebec | Quebec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval | GlaxoSmithKline |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total prostate volume | Trans rectal ultra sound 3 dimensional volume evaluation | 3 months after start of therapy | |
Secondary | EPIC questionnaire urinary function and bother scores | Expanded Prostate Cancer Index Composite | baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | EPIC questionnaire sexual function and bother scores | Expanded Prostate Cancer Index Composite | baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | EPIC questionnaire bowel function and bother scores | Expanded Prostate Cancer Index Composite | baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | EPIC questionnaire hormonal function and bother scores | Expanded Prostate Cancer Index Composite | baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | IPSS scores | International Prostate Symptom Score (I-PSS) | baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | Acute urinary retention rates | Common Terminology Criteria for Adverse Events (CTCAE) | 0 to 6 months post-implant | |
Secondary | SF-12 Quality of life questionnaire results | International Quality of Life Assessment - Short Form | baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | Rate of gynecomastia and breast tenderness | Common Terminology Criteria for Adverse Events (CTCAE) | 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | Serum testosterone | testosterone blood level | 3 months pre-implant, pre-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | Anemia | haemoglobin blood level | baseline, pre-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | Abnormal liver function tests | Blood level of Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Bilirubin, Gamma-glutamyltransferase (GGT), L-lactate dehydrogenase (LD). | 6 weeks pre-implant, pre-implant, 3 months post-implant | |
Secondary | Serum PSA | serum testosterone blood level | baseline, pre-implant, 3,6,12,18 and 24 months post-implant | |
Secondary | Adverse events recording | Common Terminology Criteria for Adverse Events (CTCAE) | 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant |
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