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Semen Analysis After Proton Therapy for Prostate Cancer (PR08)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072513
First Posted: February 22, 2010
Last Update Posted: April 6, 2016
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.
Information provided by (Responsible Party):
University of Florida
  Purpose
The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy.

Condition Intervention
Prostate Cancer Other: Semen analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone

Resource links provided by NLM:


Further study details as provided by University of Florida:

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

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


Enrollment: 31
Study Start Date: March 2010
Study Completion Date: July 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Semen analysis
Analysis of semen before and after proton radiation therapy.
Other: Semen analysis
Semen analysis before and after proton radiation therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
  More Information

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.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01072513     History of Changes
Other Study ID Numbers: UFPTI-0908-PR08
First Submitted: February 19, 2010
First Posted: February 22, 2010
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases