Prostate CancerNCT01968538
Metabolomic Study for Localized Prostate Cancer
An observational study of Prostate Cancer, run by Georgetown University at 1 site in United States.
Trial summary
Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2024
- 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 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 prostate cancer patients vs. 200 healthy men
Who may be able to join
- Males who are older than 18 years old,
- with clinically localized prostate cancer
- are receiving radiation therapy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Arlington, Virginia, 22209
About this study
Official title: A Pilot Study to Establish a Standardized Protocol for Omic Analysis of Patients With Clinically Localized Prostate Cancer Receiving Radiation Therapy
Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Also called Prostate stereotactic body radiation therapy (SBRT) and intensive modulated radiation therapy (IMRT) or the combination of both (boost)
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Patients | Prostate cancer patients who underwent radiation therapy Receives: Radiation: Radiation Therapy | |
| Healthy control | age-matched male who has no known prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular changes in biofluid
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 posted24 Oct 2013 (estimated)
- Study startJan 2009
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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.
- 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
- Prospective
- Enrolment
- 400 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
- NCT01968538
- Sponsor's protocol ID
- 2009-096
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2013
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Establish a Standardized Protocol for Omic Analysis of Patients With Clinically Localized Prostate Cancer Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT01968538
- Acronym / sponsor ID
- 2009-096
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Oct 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.
Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Patients | – | Radiation: Radiation TherapyProstate cancer patients who underwent radiation therapy |
| Healthy control | – | –age-matched male who has no known prostate cancer |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 prostate cancer patients vs. 200 healthy men
Key inclusion criteria (3 listed)
- Males who are older than 18 years old,
- with clinically localized prostate cancer
- are receiving radiation therapy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Radiation TherapyAlso: Prostate stereotactic body radiation therapy (SBRT) and intensive modulated radiation therapy (IMRT) or the combination of both (boost) | Radiation | Prostate Cancer Patients |
Primary outcome
molecular changes in biofluid
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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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, 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 1 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 28 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?
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?
molecular changes in biofluid (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 28 Feb 2023.