Prostate CancerSIBNCT02177292
High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
A study testing Radiation Therapy in people with Prostate Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT). 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?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2010to 17 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed, adenocarcinoma of the prostate
- T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0
- Karnofsky Performance Scale > 70.
- Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
- No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
- Patients must sign a study-specific consent form prior to registration.
- No evidence of distant metastases (Bone scanning)
Who cannot join
- Clinical or pathological evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
- History of prior chemotherapy
- History of prior pelvic radiation therapy
- Children (age < 18).
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients
The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
Read the detailed description
In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.
It is hoped that these newer technologies will:
- allow a higher daily dose of radiation to the tumor and pelvic nodes
- avoid nearby normal tissue and organs like the rectum and bladder
- prevent the cancer from spreading or coming back
- 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 Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
| Study group | Role | What they receive |
|---|---|---|
| IMRT & IGRT Radiation Therapy | Experimental | In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 4 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 7 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 10 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 13 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 16 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 19 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 22 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 25 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 31 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 37 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 43 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 49 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Measured: 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start23 Jun 2010
- Primary completion2 Mar 2026
- Study completion17 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hall, Medical College of Wisconsin
- Investigators
- William Hall, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177292
- Sponsor's protocol ID
- PRO00013374
- Acronym
- SIB
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4.
PubMed 17544601
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02177292
- Acronym / sponsor ID
- SIB / PRO00013374
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 23 Jun 2010 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 17 Aug 2027 (estimated)
- First posted
- 27 Jun 2014 (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.
The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
Detailed description
In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.
It is hoped that these newer technologies will:
- allow a higher daily dose of radiation to the tumor and pelvic nodes
- avoid nearby normal tissue and organs like the rectum and bladder
- prevent the cancer from spreading or coming back
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT & IGRT Radiation Therapy | Experimental | Radiation: Radiation TherapyIn this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed, adenocarcinoma of the prostate
- T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0
- Karnofsky Performance Scale > 70.
- Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
- No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
Key exclusion criteria (5 listed)
- Clinical or pathological evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
- History of prior chemotherapy
- History of prior pelvic radiation therapy
- Children (age < 18).
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: Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). | Radiation | IMRT & IGRT Radiation Therapy |
Primary outcome
Change from baseline PSA level
Time frame: 4 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 7 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 10 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 13 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 16 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 19 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 22 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 25 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 31 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 37 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 43 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 49 months
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
Time frame: 55 months
PSA level in blood is measured in units of nanograms per milliliter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 17544601Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4.
- Individual participant dataSharing planned: No
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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.
William Hall, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Prostate Cancer, run by Medical College of Wisconsin 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline PSA level (time frame: 4 months). The study lists 13 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 NCT02177292, which also lists 1 linked publication.
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 8 Oct 2026.