Prostate CancerPhase 2NCT00214136
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
A Phase 2 study testing radiotherapy in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course 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
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Prostate cancer stage T-T3
- Predicted risk of lymph node involvement > 15%
- Gleason > 7
Who cannot join
- Distance metastases
- Use of anti-coagulant therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
- Conditions
- Prostate Cancer
- Being tested
- radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
prostate radiation to 70Gy; nodal radiation to 56Gy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | prostate radiation to 70Gy, lymph nodes to 56Gy Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Expected Toxicities
Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.
Measured: Up to 5 years
Secondary outcomes (1)
To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival
Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.
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 posted21 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Ritter, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214136
- Sponsor's protocol ID
- RO04807
- Other IDs
- P01CA088960, H-2004-0472, NCI-2011-00947, A533300, SMPH\HUMAN ONCOLOGY
- Status last verified
- Aug 2021
- First submitted
- 13 Sep 2005
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
- ClinicalTrials.gov ID
- NCT00214136
- Acronym / sponsor ID
- RO04807
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 12 Oct 2017
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 examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: radiotherapyprostate radiation to 70Gy, lymph nodes to 56Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prostate cancer stage T-T3
- Predicted risk of lymph node involvement > 15%
- Gleason > 7
Key exclusion criteria (2 listed)
- Distance metastases
- Use of anti-coagulant therapy
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 |
|---|---|---|
| radiotherapyprostate radiation to 70Gy; nodal radiation to 56Gy | Radiation | 1 |
Primary outcome
Number of Participants Experiencing Expected Toxicities
Time frame: Up to 5 years
Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.
1 secondary outcome
To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Mark Ritter, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiotherapy in people with Prostate Cancer, run by University of Wisconsin, Madison 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 4 Aug 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing Expected Toxicities (time frame: Up to 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 4 Aug 2021.