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Semen Analysis After Proton Therapy for Prostate Cancer (PR08)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01072513
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Semen analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone
Study Start Date : March 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Semen analysis
Analysis of semen before and after proton radiation therapy.
Other: Semen analysis
Semen analysis before and after proton radiation therapy.




Primary Outcome Measures :
  1. Post treatment sperm count [ Time Frame: 12 months after radiation therapy ]

Secondary Outcome Measures :
  1. Compare changes in sperm motility, sperm morphology and semen PH. [ Time Frame: 12 months after radiation therapy ]
    This is composite measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072513


Locations
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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
Additional Information:
Publications:
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.

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01072513    
Other Study ID Numbers: UFPTI-0908-PR08
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by University of Florida:
Semen Analysis, Prostate Cancer, Proton Radiation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases