Clinical trial NCT01072513: Semen Analysis After Proton Therapy for Prostate Cancer
Official title: Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Semen Analysis, Prostate Cancer, Proton Radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy.


Eligibility criteria: Inclusion Criteria:

- Diagnosis of low to intermediate risk prostate cancer and elected to have proton radiation therapy at University of Florida Proton Therapy Institute (UFPTI).

Exclusion Criteria:

* Current use of Flomax, Hytrin, Cardura, Uroxatral, or Rapaflo.
* History of vasectomy.
* Current use of Lupron, Zoladex, Trelstar, Casodex, Eulexin.
* Current use of Avodart or Proscar.

Primary outcomes:
measure: Post treatment sperm count
timeFrame: 12 months after radiation therapy
Secondary outcomes:
measure: Compare changes in sperm motility, sperm morphology and semen PH.
timeFrame: 12 months after radiation therapy
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Bradford S Hoppe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
citation: Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
citation: Jang T, Bekelman J, Liu Y, et al. Visits to urologists and radiation oncologists prior to treatment decision making for clinically localized prostate cancer. Journal of Clinical Oncology 2007;25.
citation: Grocela J, Mauceri T, Zietman A. New life after prostate brachytherapy? Considering the fertile female partner of the brachytherapy patient. BJU Int. 2005 Oct;96(6):781-2. doi: 10.1111/j.1464-410X.2005.05764.x.
citation: Mydlo JH, Lebed B. Does brachytherapy of the prostate affect sperm quality and/or fertility in younger men? Scand J Urol Nephrol. 2004;38(3):221-4. doi: 10.1080/00365590410025451.
citation: Steinsvik EA, Fossa SD, Lilleby W, Eilertsen K. Fertility issues in patients with prostate cancer. BJU Int. 2008 Sep;102(7):793-5. doi: 10.1111/j.1464-410X.2008.07739.x. Epub 2008 May 16.
citation: King CR, Lo A, Kapp DS. Testicular dose from prostate cyberknife: a cautionary note. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):636-7; author reply 637. doi: 10.1016/j.ijrobp.2008.09.004. No abstract available.
citation: Boehmer D, Badakhshi H, Kuschke W, Bohsung J, Budach V. Testicular dose in prostate cancer radiotherapy: impact on impairment of fertility and hormonal function. Strahlenther Onkol. 2005 Mar;181(3):179-84. doi: 10.1007/s00066-005-1282-1.
citation: Piroth MD, Hensley F, Wannenmacher M, Zierhut D. [Male gonadal dose in adjuvant 3-d-pelvic irradiation after anterior resection of rectal cancer. Influence to fertility]. Strahlenther Onkol. 2003 Nov;179(11):754-9. doi: 10.1007/s00066-003-1108-y. German.
citation: Centola GM, Keller JW, Henzler M, Rubin P. Effect of low-dose testicular irradiation on sperm count and fertility in patients with testicular seminoma. J Androl. 1994 Nov-Dec;15(6):608-13.
citation: Hahn EW, Feingold SM, Simpson L, Batata M. Recovery from aspermia induced by low-dose radiation in seminoma patients. Cancer. 1982 Jul 15;50(2):337-40. doi: 10.1002/1097-0142(19820715)50:23.0.co;2-6.