Prostate CancerPR-PROSNCT01766492
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
An observational study of Prostate Cancer and Localized Malignant Neoplasm, run by Georgetown University at 1 site in United States.
Trial summary
Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer, Localized Malignant Neoplasm
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2025
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men (> 18 y/o) with clinically localized prostate cancer,
Who may be able to join
- Histologically confirmed adenocarcinoma of prostate
- Signed study-specific consent
- Prostate Specific Antigen (PSA) within 60 days of registration
Who cannot join
- Prior pelvic radiotherapy
- Prior radical prostate surgery
- Medical or psychiatric illness that would interfere with treatment or follow up
- Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Robyn A Cyr, 202-444-3068, Robyn.A.Cyr@gunet.georgetown.edu
Sean P Collins, MD, PhD, 202-444-3292, spc9@gunet.georgetown.edu
About this study
Official title: Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)
Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.
Read the detailed description
Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):
The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.
Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.
Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.
Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.
- Conditions
- Prostate Cancer, Localized Malignant Neoplasm
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- prostate cancer, CyberKnife
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called CyberKnife radiosurgery
Stereotactic body radiation therapy for prostate
| Study group | Role | What they receive |
|---|---|---|
| male (age > 18 y/o) with prostate cancer | Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
Use questionnaire to assess patient's symptoms regarding fatigue
Measured: 2 years
urinary symptoms
Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
Measured: 24 months
bowel symptoms
Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
Measured: 24 months
sexual function
Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
Measured: 24 months
Secondary outcomes (2)
cancer control
clinical evidence of localized and distal cancer controls
Measured: 24 months
toxicity symptoms
Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Georgetown UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean P Collins, MD, PhD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766492
- Sponsor's protocol ID
- 2012-1175
- Acronym
- PR-PROS
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2013
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: NO individual data will be made available
Publications
Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
PubMed 17482880Dess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31.
PubMed 29487023
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)
- ClinicalTrials.gov ID
- NCT01766492
- Acronym / sponsor ID
- PR-PROS / 2012-1175
- Conditions
- Prostate Cancer, Localized Malignant Neoplasm
- Keywords
- prostate cancer, CyberKnife
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 11 Jan 2013 (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.
Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.
Detailed description
Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):
The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.
Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.
Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.
Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male (age > 18 y/o) with prostate cancer | – | Radiation: Stereotactic Body Radiation Therapy (SBRT)Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men (> 18 y/o) with clinically localized prostate cancer,
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of prostate
- Signed study-specific consent
- Prostate Specific Antigen (PSA) within 60 days of registration
Key exclusion criteria (4 listed)
- Prior pelvic radiotherapy
- Prior radical prostate surgery
- Medical or psychiatric illness that would interfere with treatment or follow up
- Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: CyberKnife radiosurgeryStereotactic body radiation therapy for prostate | Radiation | male (age > 18 y/o) with prostate cancer |
Primary outcome
fatigue
Time frame: 2 years
Use questionnaire to assess patient's symptoms regarding fatigue
urinary symptoms
Time frame: 24 months
Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
bowel symptoms
Time frame: 24 months
Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
sexual function
Time frame: 24 months
Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
2 secondary outcomes
cancer control
Time frame: 24 months
toxicity symptoms
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 17482880Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
- Derived from this study: PubMed 29487023Dess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31.
- Individual participant dataSharing planned: No. NO individual data will be made available
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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.
Sean P Collins, MD, PhD principal investigator
Georgetown University Hospital
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 and Localized Malignant Neoplasm, run by Georgetown University 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 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malika T Danner (202-444-3068, mtd@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT01766492, which also lists 2 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 23 Feb 2023.