Semen Analysis After Proton Therapy for Prostate Cancer

NCT01072513 | Completed

• 1 other identifier: UFPTI-0908-PR08
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Semen Analysis, Prostate Cancer, Proton Radiation

Outcome Measures

Primary Outcomes (1)

• Post treatment sperm count

  12 months after radiation therapy

Secondary Outcomes (1)

• Compare changes in sperm motility, sperm morphology and semen PH.

  12 months after radiation therapy

Study Arms (1)

Semen analysis

OTHER

Analysis of semen before and after proton radiation therapy.

Other: Semen analysis

Interventions

Semen analysis OTHER

Semen analysis before and after proton radiation therapy.

Semen analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (11)

• 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.

  PMID: 19474385 BACKGROUND

• 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.

  PMID: 18354103 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16153199 BACKGROUND

• 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.

  PMID: 15204375 BACKGROUND

• 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.

  PMID: 18489529 BACKGROUND

• 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.

  PMID: 19147028 BACKGROUND

• 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.

  PMID: 15756522 BACKGROUND

• 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.

  PMID: 14605745 BACKGROUND

• 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.

  PMID: 7721664 BACKGROUND

• 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.

  PMID: 7083140 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Semen Analysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bradford S Hoppe, MD, MPH

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

US (1)