Prostate CancerPR08NCT01072513
Semen Analysis After Proton Therapy for Prostate Cancer
A study testing Semen analysis in people with Prostate Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Semen analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of low to intermediate risk prostate cancer and elected to have proton radiation therapy at University of Florida Proton Therapy Institute (UFPTI).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone
The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy.
- Conditions
- Prostate Cancer
- Being tested
- Semen analysis
- Keywords
- Semen Analysis, Prostate Cancer, Proton Radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semen analysisOther
Semen analysis before and after proton radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Semen analysis | Other | Analysis of semen before and after proton radiation therapy. Receives: Other: Semen analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post treatment sperm count
Measured: 12 months after radiation therapy
Secondary outcomes (1)
Compare changes in sperm motility, sperm morphology and semen PH.
This is composite measure
Measured: 12 months after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradford S Hoppe, MD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072513
- Sponsor's protocol ID
- UFPTI-0908-PR08
- Acronym
- PR08
- Status last verified
- Apr 2016
- First submitted
- 19 Feb 2010
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
PubMed 19474385Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
PubMed 18354103Jang 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.
Grocela J, Mauceri T, Zietman A. New life after prostate brachytherapy? Considering the fertile female partner of the brachytherapy patient. BJU Int. 2005 Oct;96(6):781-2. doi: 10.1111/j.1464-410X.2005.05764.x.
PubMed 16153199Mydlo JH, Lebed B. Does brachytherapy of the prostate affect sperm quality and/or fertility in younger men? Scand J Urol Nephrol. 2004;38(3):221-4. doi: 10.1080/00365590410025451.
PubMed 15204375Steinsvik EA, Fossa SD, Lilleby W, Eilertsen K. Fertility issues in patients with prostate cancer. BJU Int. 2008 Sep;102(7):793-5. doi: 10.1111/j.1464-410X.2008.07739.x. Epub 2008 May 16.
PubMed 18489529King CR, Lo A, Kapp DS. Testicular dose from prostate cyberknife: a cautionary note. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):636-7; author reply 637. doi: 10.1016/j.ijrobp.2008.09.004. No abstract available.
PubMed 19147028Boehmer D, Badakhshi H, Kuschke W, Bohsung J, Budach V. Testicular dose in prostate cancer radiotherapy: impact on impairment of fertility and hormonal function. Strahlenther Onkol. 2005 Mar;181(3):179-84. doi: 10.1007/s00066-005-1282-1.
PubMed 15756522Piroth MD, Hensley F, Wannenmacher M, Zierhut D. [Male gonadal dose in adjuvant 3-d-pelvic irradiation after anterior resection of rectal cancer. Influence to fertility]. Strahlenther Onkol. 2003 Nov;179(11):754-9. doi: 10.1007/s00066-003-1108-y. German.
PubMed 14605745Centola GM, Keller JW, Henzler M, Rubin P. Effect of low-dose testicular irradiation on sperm count and fertility in patients with testicular seminoma. J Androl. 1994 Nov-Dec;15(6):608-13.
PubMed 7721664Hahn EW, Feingold SM, Simpson L, Batata M. Recovery from aspermia induced by low-dose radiation in seminoma patients. Cancer. 1982 Jul 15;50(2):337-40. doi: 10.1002/1097-0142(19820715)50:23.0.co;2-6.
PubMed 7083140
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone
- ClinicalTrials.gov ID
- NCT01072513
- Acronym / sponsor ID
- PR08 / UFPTI-0908-PR08
- Conditions
- Prostate Cancer
- Keywords
- Semen Analysis, Prostate Cancer, Proton Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semen analysis | Other | Other: Semen analysisAnalysis of semen before and after proton radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of low to intermediate risk prostate cancer and elected to have proton radiation therapy at University of Florida Proton Therapy Institute (UFPTI).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semen analysisSemen analysis before and after proton radiation therapy. | Other | Semen analysis |
Primary outcome
Post treatment sperm count
Time frame: 12 months after radiation therapy
1 secondary outcome
Compare changes in sperm motility, sperm morphology and semen PH.
Time frame: 12 months after radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Background: PubMed 19474385Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
- Background: PubMed 18354103Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
- BackgroundJang 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.
- Background: PubMed 16153199Grocela J, Mauceri T, Zietman A. New life after prostate brachytherapy? Considering the fertile female partner of the brachytherapy patient. BJU Int. 2005 Oct;96(6):781-2. doi: 10.1111/j.1464-410X.2005.05764.x.
- Background: PubMed 15204375Mydlo JH, Lebed B. Does brachytherapy of the prostate affect sperm quality and/or fertility in younger men? Scand J Urol Nephrol. 2004;38(3):221-4. doi: 10.1080/00365590410025451.
- Background: PubMed 18489529Steinsvik EA, Fossa SD, Lilleby W, Eilertsen K. Fertility issues in patients with prostate cancer. BJU Int. 2008 Sep;102(7):793-5. doi: 10.1111/j.1464-410X.2008.07739.x. Epub 2008 May 16.
- Background: PubMed 19147028King CR, Lo A, Kapp DS. Testicular dose from prostate cyberknife: a cautionary note. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):636-7; author reply 637. doi: 10.1016/j.ijrobp.2008.09.004. No abstract available.
- Background: PubMed 15756522Boehmer D, Badakhshi H, Kuschke W, Bohsung J, Budach V. Testicular dose in prostate cancer radiotherapy: impact on impairment of fertility and hormonal function. Strahlenther Onkol. 2005 Mar;181(3):179-84. doi: 10.1007/s00066-005-1282-1.
- Background: PubMed 14605745Piroth MD, Hensley F, Wannenmacher M, Zierhut D. [Male gonadal dose in adjuvant 3-d-pelvic irradiation after anterior resection of rectal cancer. Influence to fertility]. Strahlenther Onkol. 2003 Nov;179(11):754-9. doi: 10.1007/s00066-003-1108-y. German.
- Background: PubMed 7721664Centola GM, Keller JW, Henzler M, Rubin P. Effect of low-dose testicular irradiation on sperm count and fertility in patients with testicular seminoma. J Androl. 1994 Nov-Dec;15(6):608-13.
- Background: PubMed 7083140Hahn EW, Feingold SM, Simpson L, Batata M. Recovery from aspermia induced by low-dose radiation in seminoma patients. Cancer. 1982 Jul 15;50(2):337-40. doi: 10.1002/1097-0142(19820715)50:23.0.co;2-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford S Hoppe, MD, MPH principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semen analysis in people with Prostate Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post treatment sperm count (time frame: 12 months after radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072513, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.