Phase 4
Completed N=742
Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT01294592 ↗
Enrolled (actual)
742
Serious AEs
8.4%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach — -3.2; -0.9; -4.5; -2.4 Scores on a scale — p=<0.001
Summary
Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH).
Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire.
After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach |
-3.2; -0.9; -4.5; -2.4; -4.6; -3.2 | <0.001 sig |
| SECONDARY Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach |
225; 149; 182; 90; 161; 76 | — |
| SECONDARY Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach |
-1.3; -0.4; -1.8; -1.0; -1.9; -1.3 | — |
| SECONDARY Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach |
-0.8; -0.3; -1.1; -0.7; -1.2; -0.9 | — |
| SECONDARY Number of Events of Clinical Progression (CP) of BPH |
48; 94; 17; 14 | — |
| SECONDARY Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH |
65; 108; 59; 97; 2; 4 | — |
| SECONDARY Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries |
6; 3; 5; 1; 2; 1 | — |
| SECONDARY Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach |
119; 122; 196; 206; 272; 209 | — |
| SECONDARY Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach |
109; 103; 206; 225; 224; 166 | — |
| SECONDARY Exposure to Study Drug |
639.8; 566.3 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization |
190; 119; 95; 38; 25; 19 | — |
Eligibility Criteria
- Males aged ≥50 years.
- A confirmed clinical diagnosis of BPH.
- International Prostate Symptom Score (IPSS) 8-19 at Visit 1 (screening).
- Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS).
- Total serum prostate specific antigen (PSA) ≥1.5 ng/mL at Visit 1 (screening).
- Willing and able to give signed written informed consent and comply with study procedures.
- Fluent and literate in local language with the ability to read, comprehend and record information on the IPSS and BII questionnaires.
- Able to swallow and retain oral medication.
- Willing and able to participate in the study for the full 2 years.
- Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug plus 3 months to allow clearance of any altered sperm after the last dose of study treatment.
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Note: If total serum PSA is >4 ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further Digital rectal examination (DRE), review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice
Exclusion Criteria
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Total serum PSA >10.0 ng/mL at Visit 1 (screening).
- History or evidence of prostate cancer (e.g. positive biopsy or ultrasound within the previous 6 months, suspicious DRE and/or rising PSA).
Excluded medication and therapies Current or any prior use of the following prohibited medications
- a 5α-reductase inhibitor (finasteride or dutasteride),
- anti-cholinergics (e.g. oxybutynin, propantheline)
- an alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) for BPH or Lower urinary tract symptoms (LUTS)
- any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the previous 6 months.
- any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6 months of the Visit 1
- any investigational or marketed study drug within 30 days or 5 half-lives, (whichever is longer), preceding the first dose of study treatment.
Current use of:
- any alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin)
- anabolic steroids.
- drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
- Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study.
Have a known (immediate or delayed) hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GlaxoSmithKline contraindicates their participation.
Recent Medical Procedures
- Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH.
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation ( 250 mL (suprapubic ultrasound) at Visit 1 (screening)..
- Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
- History of 'first dose' hypotensive episode on initiation of a
Data sourced from ClinicalTrials.gov (NCT01294592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.