Overview

This trial is active, not recruiting.

Conditions prostate cancer, erectile dysfunction, lower urinary tract symptoms
Treatments administration of a lhrh agonist and bicalutamide, administration of bicalutamide, dutasteride and tamoxifen
Phase phase 2
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator GlaxoSmithKline
Start date March 2009
End date June 2015
Trial size 88 participants
Trial identifier NCT00866554, DUT112661, Health Canada-112661

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Administration of a 3-month treatment with an LHRH agonist (chosen by the treating radiation oncologist) and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
administration of a lhrh agonist and bicalutamide Bicalutamide(Casodex)
3-month treatment with an LHRH agonist chosen by the treating radiation oncologist and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
(Experimental)
Administration of Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure. Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.
administration of bicalutamide, dutasteride and tamoxifen Bicalutamide (Casodex)
Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure. Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.

Primary Outcomes

Measure
Total prostate volume
time frame: 3 months after start of therapy

Secondary Outcomes

Measure
EPIC questionnaire urinary function and bother scores
time frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
EPIC questionnaire sexual function and bother scores
time frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
EPIC questionnaire bowel function and bother scores
time frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
EPIC questionnaire hormonal function and bother scores
time frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
IPSS scores
time frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
Acute urinary retention rates
time frame: 0 to 6 months post-implant
SF-12 Quality of life questionnaire results
time frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
Rate of gynecomastia and breast tenderness
time frame: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant
Serum testosterone
time frame: 3 months pre-implant, pre-implant, 3,6,12,18 and 24 months post-implant
Anemia
time frame: baseline, pre-implant, 3,6,12,18 and 24 months post-implant
Abnormal liver function tests
time frame: 6 weeks pre-implant, pre-implant, 3 months post-implant
Serum PSA
time frame: baseline, pre-implant, 3,6,12,18 and 24 months post-implant
Adverse events recording
time frame: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy
Principal investigator Andre-Guy Martin, MD
Description Permanent implant prostate brachytherapy is recognized as the treatment method for prostate cancer that results in the least amount of sexual side effects including erectile dysfunction (ED). However prostate brachytherapy is often limited to patients with a prostate volume less than 50cc because of dosimetric and technical considerations. To counter this fact patients with a prostate larger than 50cc are offered neoadjuvant hormonal therapy to reduce their prostate volume to a value less than 50cc. The pharmacological method most often employed involves treatment with an LHRH agonist, which also involves multiple adverse effects for patients including ED in the majority of patients. This approach may also involve other disadvantages including a possibility of increased cardiovascular mortality a possible increase in urinary toxicity and a reduction in health-related quality of life in patients treated with neoadjuvant hormonal therapy. Despite theses facts, neoadjuvant hormonal therapy remains essentially the sole method used to reduce prostate volume prior to prostate brachytherapy. One study has evaluated the efficacy of a neoadjuvant regimen without an LHRH agonist, comprised of Dutasteride and Bicalutamide to reduce prostate volume. This treatment could theoretically have fewer effects on sexual function and quality of life and could also possibly reduce urinary toxicity of brachytherapy. Nonetheless, these factors have never been evaluated. The cytoreductive efficacy of Bicalutamide and Dutasteride have never been directly compared to standard treatments. The current study is necessary to determine the effects of a neoadjuvant regimen of Bicalutamide and Dutasteride on prostate volume, sexual function, urinary toxicity and quality of life as compared to standard treatment. If it can be determined that there is an advantage with Bicalutamide and Dutasteride this regimen could become a standard of care for prostate cytoreduction prior to brachytherapy.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.