Semen Analysis After Proton Therapy for Prostate Cancer (PR08)
This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01072513
First received: February 19, 2010
Last updated: March 27, 2013
Last verified: March 2013
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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 27, 2013 |
| 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 June 18, 2013