Prostate CancerNCT01059513
Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
An observational study of Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2010to 19 Mar 2020
- Phase
- Observational
- 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
Study population: Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
Who may be able to join
- Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
- The ability to understand and willingness to sign a written informed consent are necessary.
Who cannot join
- Patients with tumor parameters that fall outside of the inclusion criteria.
- Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
- Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
- A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
- The use of other concurrent investigational agents.
- There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.
- No life expectancy restrictions will apply.
- Performance status will not be considered.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.
- Conditions
- Prostate Cancer
- Keywords
- T1c, T2a, T2b
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify patient quality of life after prostate SBRT using validated questionnaire tools
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study start26 Jan 2010
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher King, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059513
- Sponsor's protocol ID
- 10-001787
- Status last verified
- May 2020
- First submitted
- 29 Jan 2010
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01059513
- Acronym / sponsor ID
- 10-001787
- Conditions
- Prostate Cancer
- Keywords
- T1c, T2a, T2b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Jan 2010 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 1 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.
This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
Key inclusion criteria (2 listed)
- Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
- The ability to understand and willingness to sign a written informed consent are necessary.
Key exclusion criteria (8 listed)
- Patients with tumor parameters that fall outside of the inclusion criteria.
- Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
- Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
- A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
- The use of other concurrent investigational agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To quantify patient quality of life after prostate SBRT using validated questionnaire tools
Time frame: 5 years
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 25 Nov 2020.
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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.
Christopher King, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Jonsson Comprehensive Cancer Center 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 2 inclusion and 8 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 25 Nov 2020. 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?
To quantify patient quality of life after prostate SBRT using validated questionnaire tools (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.