Semen Analysis After Proton Therapy for Prostate Cancer (PR08)

This study is currently recruiting participants.
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01072513
First received: February 19, 2010
Last updated: March 13, 2014
Last verified: March 2014
  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: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072513

Contacts
Contact: Intake Coordinator (877) 686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Bradford S. Hoppe, MD, MPH         
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:
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
ClinicalTrials.gov Identifier: NCT01072513     History of Changes
Other Study ID Numbers: UFPTI-0908-PR08
Study First Received: February 19, 2010
Last Updated: March 13, 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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014