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CompletedNCT01072513PR08Updated Apr 6, 2016

Semen Analysis After Proton Therapy for Prostate Cancer

An interventional study of Semen analysis in Prostate Cancer, sponsored by University of Florida. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by University of Florida · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

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

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Semen Analysis, Prostate Cancer, Proton Radiation
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 31 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Other
    Semen analysis

    Analysis of semen before and after proton radiation therapy.

    Other: Semen analysis

Interventions

  • OtherSemen analysis

    Semen analysis before and after proton radiation therapy.

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What researchers measure

Primary outcomes

  1. Post treatment sperm count

    Time frame: 12 months after radiation therapy

Secondary outcomes

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

    This is composite measure

    Time frame: 12 months after radiation therapy

07

Study locations

1 site
  • University of Florida Proton Therapy Institute
    Jacksonville, Florida 32206, United States
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References and documents

Publications

  • 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. PubMed 19474385 ↗
  • 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. PubMed 18354103 ↗
  • 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.
  • 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. PubMed 16153199 ↗
  • 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. PubMed 15204375 ↗
  • 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. PubMed 18489529 ↗
  • 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. PubMed 19147028 ↗
  • 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. PubMed 15756522 ↗
  • 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. PubMed 14605745 ↗
  • 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. PubMed 7721664 ↗
  • 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. PubMed 7083140 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01072513
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Feb 22, 2010
Start date
Mar 2010
Primary completion
Jul 2014
Completion
Jul 2015
Last update
Apr 6, 2016

Study contacts

Bradford S Hoppe, MD, MPH
principal investigator · University of Florida Proton Therapy Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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