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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Other trials in United States

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 groups in NCT00214136
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.

Mar 2005Mar 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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.

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

Results posted to the registry on 12 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	30	25

Primary outcome: Number of Participants Experiencing Expected Toxicities

Time frame: Up to 5 years. Count of participants. Unit: Participants

Measure	Experimental n = 25
Value	13

Population analysed: Only 25 of 30 participants met the minimum follow up thresholds at the time of analysis; the 5 most recently accrued participants' data was not analyzed and is not reflected.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 25 (0%)	13 of 25 (52%)	6 of 25

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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Enrolling by invitationObservational study
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Not yet recruitingPhase 1/2
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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?

On the ClinicalTrials.gov record for NCT00214136.

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.