Prostate CancerNCT03128710
Prostate Cancer Survey
An observational study of Prostate Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
There have been calls from patients, payers, healthcare providers, and policy makers for an evaluation of newer, high-cost radiation technologies compared to conventional forms of 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
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 15 Feb 2018
- 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: Patients with prostate malignancies who consent to receiving Radiation treatment at the University of Maryland, Baltimore, will be offered this survey.
Who may be able to join
- Participant is 18 years or older
- Has been diagnosed with prostate cancer
- Able to speak and read English
Who cannot join
- Participant is not being seen for prostate cancer
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Patient-relevant Adverse Events Following Prostate Radiotherapy
There have been calls from patients, payers, healthcare providers, and policy makers for an evaluation of newer, high-cost radiation technologies compared to conventional forms of radiation therapy. National attention has focused on the use of intensity modulated radiation therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the present study is to determine whether the type of radiation treatment received by the patients can result in a reduction in patient-relevant side effects following prostate irradiation. The analysis will be performed by obtaining patient answered surveys looking at side effects.
- Conditions
- Prostate Cancer
- Keywords
- Survey, Focus Group, Treatment Preferences
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survey Group | Approximately 300 patients with prostate cancer will be provided a survey investigating their treatment preferences and side effects faced during and after receiving radiation treatment. | |
| Focus Group | Approximately 75 participants will participate in a focus group. All participants will have completed radiation treatment and will discuss side effects after having received radiation, as well as their quality of life while receiving radiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine patient preference weights for side effect reduction in radiation treatment of prostate cancer
Investigators will use an anonymous survey and results from multiple focus groups to quantify the relative importance/significance of commonly encountered side effects experienced by patients following external beam radiation therapy. We will complete descriptive statistics as a means of understanding the data obtained by survey responses. Additionally, comparative analyses may be undertaken to evaluate differences between different side effects experienced.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start15 Mar 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
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 University of Maryland, BaltimoreThe 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
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Mark Mishra, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128710
- Sponsor's protocol ID
- HP-00073268
- Status last verified
- Nov 2024
- First submitted
- 19 Apr 2017
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Patient-relevant Adverse Events Following Prostate Radiotherapy
- ClinicalTrials.gov ID
- NCT03128710
- Acronym / sponsor ID
- HP-00073268
- Conditions
- Prostate Cancer
- Keywords
- Survey, Focus Group, Treatment Preferences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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.
There have been calls from patients, payers, healthcare providers, and policy makers for an evaluation of newer, high-cost radiation technologies compared to conventional forms of radiation therapy. National attention has focused on the use of intensity modulated radiation therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the present study is to determine whether the type of radiation treatment received by the patients can result in a reduction in patient-relevant side effects following prostate irradiation. The analysis will be performed by obtaining patient answered surveys looking at side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survey Group | – | –Approximately 300 patients with prostate cancer will be provided a survey investigating their treatment preferences and side effects faced during and after receiving radiation treatment. |
| Focus Group | – | –Approximately 75 participants will participate in a focus group. All participants will have completed radiation treatment and will discuss side effects after having received radiation, as well as their quality of life while receiving radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate malignancies who consent to receiving Radiation treatment at the University of Maryland, Baltimore, will be offered this survey.
Key inclusion criteria (3 listed)
- Participant is 18 years or older
- Has been diagnosed with prostate cancer
- Able to speak and read English
Key exclusion criteria (2 listed)
- Participant is not being seen for prostate cancer
- Under the age of 18
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 determine patient preference weights for side effect reduction in radiation treatment of prostate cancer
Time frame: 3 years
Investigators will use an anonymous survey and results from multiple focus groups to quantify the relative importance/significance of commonly encountered side effects experienced by patients following external beam radiation therapy. We will complete descriptive statistics as a means of understanding the data obtained by survey responses. Additionally, comparative analyses may be undertaken to evaluate differences between different side effects experienced.
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 5 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
Mark Mishra, MD principal investigator
University of Maryland, Baltimore
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 University of Maryland, Baltimore 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 2 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 5 Nov 2024. 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 determine patient preference weights for side effect reduction in radiation treatment of prostate cancer (time frame: 3 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 5 Nov 2024.