Semen Analysis After Proton Therapy for Prostate Cancer

NCT ID: NCT01072513

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Semen analysis

Analysis of semen before and after proton radiation therapy.

Group Type OTHER

Semen analysis

Intervention Type OTHER

Semen analysis before and after proton radiation therapy.

Interventions

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Semen analysis

Semen analysis before and after proton radiation therapy.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradford S Hoppe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Locations

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University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19474385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18354103 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16153199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15204375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18489529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19147028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15756522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14605745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7721664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7083140 (View on PubMed)

Other Identifiers

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UFPTI-0908-PR08

Identifier Type: -

Identifier Source: org_study_id

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