AzTrials
AzTrials

Prostate CancerPhase 3NCT00244309

Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer

A Phase 3 study testing tamsulosin and/or dutasteride in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

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 whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
tamsulosin and/or dutasteride
How many people
348 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jun 2006
Phase
Phase 3
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

  • Patient is eligible for a prostate implant
  • Patient is greater than 18 years of age
  • Patient is able to give informed consent
  • Patient does not currently take Flomax, Dutasteride or Finasteride
  • Patient does not have a known hypersensitivity reaction to Flomax or Dutasteride

Who cannot join

  • Patients who have a known hypersensitivity reaction to tamsulosin, dutasteride or finasteride and those patients who are already on any prior to prostate implantation
  • Patients who are taking a PDE-5 inhibitor including sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra) are ineligible to participate unless they are willing to discontinue using those drugs one week prior to their implant and for three months after the implant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: A Randomized Trial of Tamsulosin and/or Dutasteride Versus Placebo to Relieve Urinary Symptoms After Brachytherapy for the Treatment of Localized Prostate Cancer

The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.

Read the detailed description

Image-guided transperineal permanent prostate brachytherapy (PI) is an accepted curative treatment option for patients with early stage prostate cancer. The most severe side effect of PI is urinary retention requiring intermittent self-catheterization (ISC). This study will assess the ability of pharmacologic intervention to ameliorate the post-operative side effect of PI. The use of both tamsulosin and dutasteride is proposed to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with prostate adenocarcinoma after prostate implant.

Conditions
Prostate Cancer
Being tested
tamsulosin and/or dutasteride
Keywords
brachytherapy, urinary symptoms
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • tamsulosin and/or dutasterideDrug

What is being measured

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

  1. AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.

Secondary outcomes (1)

  1. Use of intermittent self-catheterization

Timeline

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

  1. First posted26 Oct 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2006
  4. Study completionJun 2006

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
348 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244309
Sponsor's protocol ID
CASE14804
Other IDs
GSK106046 (formerly 103988)
Status last verified
May 2011
First submitted
24 Oct 2005
Last updated
4 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Ragde H, Blasko JC, Grimm PD, Kenny GM, Sylvester JE, Hoak DC, Landin K, Cavanagh W. Interstitial iodine-125 radiation without adjuvant therapy in the treatment of clinically localized prostate carcinoma. Cancer. 1997 Aug 1;80(3):442-53. doi: 10.1002/(sici)1097-0142(19970801)80:33.0.co;2-x.

    PubMed 9241078

  • Ragde H, Korb LJ, Elgamal AA, Grado GL, Nadir BS. Modern prostate brachytherapy. Prostate specific antigen results in 219 patients with up to 12 years of observed follow-up. Cancer. 2000 Jul 1;89(1):135-41.

    PubMed 10897010

  • Blasko JC, Ragde H, Grimm PD. Transperineal ultrasound-guided implantation of the prostate: morbidity and complications. Scand J Urol Nephrol Suppl. 1991;137:113-8.

    PubMed 1947828

  • Kleinberg L, Wallner K, Roy J, Zelefsky M, Arterbery VE, Fuks Z, Harrison L. Treatment-related symptoms during the first year following transperineal 125I prostate implantation. Int J Radiat Oncol Biol Phys. 1994 Mar 1;28(4):985-90. doi: 10.1016/0360-3016(94)90119-8.

    PubMed 8138452

  • Terk MD, Stock RG, Stone NN. Identification of patients at increased risk for prolonged urinary retention following radioactive seed implantation of the prostate. J Urol. 1998 Oct;160(4):1379-82.

    PubMed 9751358

  • Benoit RM, Naslund MJ, Cohen JK. A comparison of complications between ultrasound-guided prostate brachytherapy and open prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):909-13. doi: 10.1016/s0360-3016(00)00506-x.

    PubMed 10863059

  • Lee N, Wuu CS, Brody R, Laguna JL, Katz AE, Bagiella E, Ennis RD. Factors predicting for postimplantation urinary retention after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1457-60. doi: 10.1016/s0360-3016(00)00784-7.

    PubMed 11121648

  • Bruno JF, Whittaker J, Song JF, Berelowitz M. Molecular cloning and sequencing of a cDNA encoding a human alpha 1A adrenergic receptor. Biochem Biophys Res Commun. 1991 Sep 30;179(3):1485-90. doi: 10.1016/0006-291x(91)91740-4.

    PubMed 1656955

  • Ramarao CS, Denker JM, Perez DM, Gaivin RJ, Riek RP, Graham RM. Genomic organization and expression of the human alpha 1B-adrenergic receptor. J Biol Chem. 1992 Oct 25;267(30):21936-45.

    PubMed 1328250

  • Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.

    PubMed 9609623

  • Lepor H. Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):901-6. doi: 10.1016/s0090-4295(98)00127-7.

    PubMed 9609624

  • Chapple CR, Wyndaele JJ, Nordling J, Boeminghaus F, Ypma AF, Abrams P. Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. A meta-analysis of two randomized, placebo-controlled, multicentre studies in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group. Eur Urol. 1996;29(2):155-67.

    PubMed 8647141

  • Schulman CC, Cortvriend J, Jonas U, Lock TM, Vaage S, Speakman MJ. Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. Analysis of a multinational, multicentre, open-label study assessing the long-term efficacy and safety in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group. Eur Urol. 1996;29(2):145-54.

    PubMed 8647140

  • Prosnitz RG, Schneider L, Manola J, Rocha S, Loffredo M, Lopes L, D'Amico AV. Tamsulosin palliates radiation-induced urethritis in patients with prostate cancer: results of a pilot study. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):563-6. doi: 10.1016/s0360-3016(99)00246-1.

    PubMed 10524406

  • Elshaikh MA, Angermeier K, Ulchaker JC, Klein EA, Chidel MA, Mahoney S, Wilkinson DA, Reddy CA, Ciezki JP. Effect of anatomic, procedural, and dosimetric variables on urinary retention after permanent iodine-125 prostate brachytherapy. Urology. 2003 Jan;61(1):152-5. doi: 10.1016/s0090-4295(02)02142-8.

    PubMed 12559287

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tamsulosin and/or dutasteride in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

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 5 inclusion and 2 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 4 May 2011. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.. 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 NCT00244309, which also lists 17 linked publications.

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 4 May 2011.

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