Efficacy and Safety of tadalafil 20 mg on demand vs. tadalafil 5 mg once-a-day in the treatment of post-radiotherapy erectile dysfunction in prostate cancer men: A randomized phase II trial

Journal of Sexual Medicine

Volumn 7, Issue 8, 2010, Pages 2851-2859

  Ricardi, Umberto ^a   Gontero, Paolo ^a   Ciammella, Patrizia ^a   Badellino, Serena ^a   Valentino, Franco ^a   Munoz, Fernando ^a   Guarneri, Alessia ^a   Rondi, Nadia ^a   Moretto, Francesco ^a   Filippi, Andrea Riccardo ^a   Ragona, Riccardo ^a   Tizzani, Alessandro ^a  

^a UNIVERSITY OF TURIN   (Italy)

Author keywords

Erectile Dysfunction; Post Radiation Therapy Erectile Dysfunction; Prostate Cancer; Radiotherapy; Tadalafil

Indexed keywords

TADALAFIL;

ADULT; AGED; ANAPHYLAXIS; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; ERECTILE DYSFUNCTION; FACE FLUSHING; FLUSHING; HUMAN; INTERNATIONAL INDEX OF ERECTILE FUNCTION; MAJOR CLINICAL STUDY; MALE; MYALGIA; NOSE CONGESTION; PATIENT COMPLIANCE; PENIS ERECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL; SEXUAL BEHAVIOR; SIDE EFFECT;

EID: 77955254526     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2010.01890.x     Document Type: Article

References (27)

1. Incrocci L, Slob AK, Levendag PC. Sexual (dys)function after radiotherapy for prostate cancer: A review. Int J Radiat Oncol Biol Phys 2002, 52:681-93.
2. Incrocci L, Koper PC, Hop WC, Slob AK. Efficacy of sildenafil in an open-label study as a continuation of a double-blind study in the treatment of erectile dysfunction after radiotherapy for prostate cancer. Urology 2003, 62:116.
3. Ohebshalom M, Parker M, Guhring P, Mulhall JP. The efficacy of sildenafil citrate following radiation therapy for prostate cancer: Temporal considerations. J Urol 2005, 174:258-62.
4. Porst H, Padma-Nathan H, Giuliano F, Anglin G, Varanese L, Rosen R. Efficacy of Tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: A randomized controlled trial. Urology 2003, 62:121-5.
5. Patterson B, Bedding A, Jewell H. The effect of intrinsic and extrinsic factors on the pharmacokinetic properties of Tadalafil (I351). Int J Impot Res 2001, 13:s43.
6. Incrocci L, Slagter C, Slob AK, Hop WCJ. A randomized, double-blind, placebo-controlled, cross-over study to assess the efficacy of tadalafil of erectile dysfunction following three-dimensional conformal external-beam radiotherapy for prostatic carcinoma. Int J Radiat Oncol Biol Phys 2006, 66:439-44.
7. Forgue ST, Patterson BE, Bedding AW, Payne CD, Phillips DL, Wrishko RE, Mitchell MI. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol 2006, 61:280-8.
8. Mc Mahon C. Comparison of efficacy, safety, and tolerability of on-demand Tadalafil and daily doses Tadalafil for the treatment of erectile dysfunction. J Sex Med 2005, 2:415-24.
9. Porst H, Giuliano F, Glina S, Ralph D, Casabé AR, Elion-Mboussa A, Shen W, Whitaker JS. Evaluation of the efficacy and safety of once-a-day dosing of Tadalafil 5 mg and 10 mg in the treatment of erectile dysfunction: Results of a multicenter, randomized duble-blind, placebo-controlled trial. Eur Urol 2006, 50:351-9.
10. Rosen R, Riley A, Wagner G, Osterloh I, Kirkpatrick J, Mishra A. The International Index of Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997, 49:822-30.
11. Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: Development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003, 13:176-81.
12. van der Wielen GJ, Vermeij M, de Jong BW, Schuit M, Marijnissen J, Kok DJ, van Weerden WM, Incrocci L. Changes in the penile arteries of the rat after fractionated irradiation of the prostate: A pilot study. J Sex Med 2009, 6:1908-13.
13. Turner SL, Adams K, Bull CA, Berry MP. Sexual dysfunction after radical radiation therapy for prostate cancer: A prospective evaluation. Urology 1999, 54:124-9.
14. van der Wielen GJ, van Putten WL, Incrocci L. Sexual function after three-dimensional conformal radiotherapy for prostate cancer: Results from a dose-escalation trial. Int J Radiat Oncol Biol Phys 2007, 68:479-84.
15. Zelefsky MJ, Cowen D, Fuks Z, Shike M, Burman C, Jackson A, Venkatramen ES, Leibel SA. Long term tolerance of high dose three-dimensional conformal radiotherapy in patients with localized prostate carcinoma. Cancer 1999, 85:2460-8.
16. Talcott JA, Rieker P, Clark JA, Propert KJ, Weeks JC, Beard CJ, Wishnow KI, Kaplan I, Loughlin KR, Richie JP, Kantoff PW. Patient-reported symptoms after primary therapy for early prostate cancer: Results of a prospective cohort study. J Clin Oncol 1998, 16:275-83.
17. Roach M, Chinn DM, Holland J, Clarke M. A pilot survey of sexual function and quality of life following 3D conformal radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys 1996, 35:869-74.
18. Fransson P, Widmark A. Does one have a sexual life 15 years after external beam radiotherapy for prostate cancer? Prospective patient-reported outcome of sexual function comparison with age-matched controls. Urol Oncol 2009, Mar 7 [Epub ahead of print] doi: 10.1016/j.urolonc.2009.01.001
19. Incrocci L, Koper PC, Hop WC, Slob AK. Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for prostate cancer: A randomized, double-blind, placebo-controlled, cross-over study. Int J Radiol Oncol Biol Phys 2001, 51:1190-5.
20. Weber DC, Bieri S, Kurtz JM, Mirabell R. Prospective pilot study of sildenafil for treatment of postradiotherapy erectile dysfunction in patients with prostate cancer. J Clin Oncol 1999, 17:34-44.
21. Teloken PE, Parker M, Mohideen N, Mulhall JP. Predictors of response to Sildenafil Citrate following radiation therapy for prostate cancer. J Sex Med 2009, 6:1135-40.
22. Padma-Nathan H, McMurray JG, Pulman WE. On demand IC351 (Cialis) enhances erectile function in patients with erectile dysfunction. Int J Impot Res 2001, 13:2-9.
23. Eardley I, Cartledge J. Tafalafil (Cialis) for men with erectile dysfunction. Int J Clin Pract 2002, 56:300-4.
24. Fugl-Meyer AR, Lodnert G, Branholm IB, Fugl-Meyer KS. On life satisfaction in male erection dysfunction. Int J Impot Res 1997, 9:141-8.
25. Lewis R, Bennett CJ, Borkon WD. Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Urology 2001, 57:960-5.
26. Brock GB. Tadalafil: A new agent for erectile dysfunction. Can J Urol 2003, 10:17-22.
27. Brock GB, McMahon CG, Chen KK. Efficacy and safety of Tadalafil for the treatment of erectile dysfunction: Results of integrated analyses. J Urol 2002, 186:1332-36.