Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Semen Analysis After Proton Therapy for Prostate Cancer (PR08)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Florida Identifier:
First received: February 19, 2010
Last updated: November 18, 2014
Last verified: November 2014

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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare changes in sperm motility, sperm morphology and semen PH. [ Time Frame: 12 months after radiation therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01072513

United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
  More Information

Additional Information:
Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin 2009;59:225-249.
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.
King CR, Lo A, Kapp DS. Testicular dose from prostate cyberknife: a cautionary note. Int J Radiat Oncol Biol Phys 2009;73:636-637; author reply 637.

Responsible Party: University of Florida Identifier: NCT01072513     History of Changes
Other Study ID Numbers: UFPTI-0908-PR08
Study First Received: February 19, 2010
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Semen Analysis, Prostate Cancer, Proton Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 27, 2015