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Trial record 43 of 117 for:    DUTASTERIDE

Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy

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ClinicalTrials.gov Identifier: NCT00866554
Recruitment Status : Unknown
Verified April 2015 by André-Guy Martin, CHU de Quebec-Universite Laval.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2009
Last Update Posted : April 16, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
André-Guy Martin, CHU de Quebec-Universite Laval

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Erectile Dysfunction Lower Urinary Tract Symptoms Drug: administration of a LHRH agonist and Bicalutamide Drug: administration of Bicalutamide, Dutasteride and Tamoxifen Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy
Study Start Date : March 2009
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LHRH agonist
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.
Drug: administration of a LHRH agonist and Bicalutamide
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.
Other Name: Bicalutamide(Casodex)

Experimental: Dutasteride, Bicalutamide, Tamoxifen

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.

Drug: administration of Bicalutamide, Dutasteride and Tamoxifen

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.

Other Names:
  • Bicalutamide (Casodex)
  • Dutasteride (Avodart)
  • Tamoxifen (Nolvadex)




Primary Outcome Measures :
  1. Total prostate volume [ Time Frame: 3 months after start of therapy ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. IPSS scores [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  6. Acute urinary retention rates [ Time Frame: 0 to 6 months post-implant ]
  7. 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 ]
  8. 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 ]
  9. Serum testosterone [ Time Frame: 3 months pre-implant, pre-implant, 3,6,12,18 and 24 months post-implant ]
  10. Anemia [ Time Frame: baseline, pre-implant, 3,6,12,18 and 24 months post-implant ]
  11. Abnormal liver function tests [ Time Frame: 6 weeks pre-implant, pre-implant, 3 months post-implant ]
  12. Serum PSA [ Time Frame: baseline, pre-implant, 3,6,12,18 and 24 months post-implant ]
  13. Adverse events recording [ Time Frame: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866554


Locations
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Canada
CHUQ- Hotel-Dieu de Quebec
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
CHU de Quebec-Universite Laval
GlaxoSmithKline
Investigators
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Principal Investigator: Andre-Guy Martin, MD CHUQ-Hotel-Dieu de Québec

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Responsible Party: André-Guy Martin, MD MSC FRCP(C) Radio-oncologue, Curiethérapeute Professeur Associé, Université Laval, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT00866554     History of Changes
Other Study ID Numbers: DUT112661
Health Canada-112661 ( Other Grant/Funding Number: GSK )
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by André-Guy Martin, CHU de Quebec-Universite Laval:
Prostate
Brachytherapy
Cytoreduction
Sexual function
Toxicity
Additional relevant MeSH terms:
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Dutasteride
Erectile Dysfunction
Lower Urinary Tract Symptoms
Genital Diseases, Male
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Urological Manifestations
Signs and Symptoms
Tamoxifen
Bicalutamide
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Androgen Antagonists