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Prostate CancerPhase 2NCT00866554

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

A Phase 2 study testing administration of a LHRH agonist and Bicalutamide and administration of Bicalutamide, Dutasteride and Tamoxifen in people with Prostate Cancer and Erectile Dysfunction, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
administration of a LHRH agonist and Bicalutamide and administration of Bicalutamide, Dutasteride and Tamoxifen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
Mar 2009to Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CHUQ- Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

Official title: Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy

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.

Read the 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.

Being tested
administration of a LHRH agonist and Bicalutamide, administration of Bicalutamide, Dutasteride and Tamoxifen
Keywords
Prostate, Brachytherapy, Cytoreduction, Sexual function, Toxicity
Medical subject headings
Prostatic Neoplasms, Erectile Dysfunction, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • administration of a LHRH agonist and BicalutamideDrug

    Also called 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.

  • administration of Bicalutamide, Dutasteride and TamoxifenDrug

    Also called Bicalutamide (Casodex), Dutasteride (Avodart), Tamoxifen (Nolvadex)

    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.

Study groups in NCT00866554
Study groupRoleWhat they receive
LHRH agonistActive comparatorAdministration 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.
Receives: Drug: administration of a LHRH agonist and Bicalutamide
Dutasteride, Bicalutamide, TamoxifenExperimentalAdministration 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.
Receives: Drug: administration of Bicalutamide, Dutasteride and Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total prostate volume

    Trans rectal ultra sound 3 dimensional volume evaluation

    Measured: 3 months after start of therapy

Secondary outcomes (13)

  1. EPIC questionnaire urinary function and bother scores

    Expanded Prostate Cancer Index Composite

    Measured: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  2. EPIC questionnaire sexual function and bother scores

    Expanded Prostate Cancer Index Composite

    Measured: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  3. EPIC questionnaire bowel function and bother scores

    Expanded Prostate Cancer Index Composite

    Measured: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  4. EPIC questionnaire hormonal function and bother scores

    Expanded Prostate Cancer Index Composite

    Measured: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  5. IPSS scores

    International Prostate Symptom Score (I-PSS)

    Measured: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  6. Acute urinary retention rates

    Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: 0 to 6 months post-implant

  7. SF-12 Quality of life questionnaire results

    International Quality of Life Assessment - Short Form

    Measured: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  8. Rate of gynecomastia and breast tenderness

    Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

  9. Serum testosterone

    testosterone blood level

    Measured: 3 months pre-implant, pre-implant, 3,6,12,18 and 24 months post-implant

  10. Anemia

    haemoglobin blood level

    Measured: baseline, pre-implant, 3,6,12,18 and 24 months post-implant

  11. Abnormal liver function tests

    Blood level of Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Bilirubin, Gamma-glutamyltransferase (GGT), L-lactate dehydrogenase (LD).

    Measured: 6 weeks pre-implant, pre-implant, 3 months post-implant

  12. Serum PSA

    serum testosterone blood level

    Measured: baseline, pre-implant, 3,6,12,18 and 24 months post-implant

  13. Adverse events recording

    Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866554
Sponsor's protocol ID
DUT112661
Other IDs
Health Canada-112661
Status last verified
May 2023
First submitted
19 Mar 2009
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing administration of a LHRH agonist and Bicalutamide and administration of Bicalutamide, Dutasteride and Tamoxifen in people with Prostate Cancer and Erectile Dysfunction, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total prostate volume (time frame: 3 months after start of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00866554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.

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