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Radiation Therapy

Intensity Modulated Radiation Therapy for Prostate Cancer (SIB Trial)

N/A

Waitlist Available

Led By Colleen A Lawton, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

Clinical or pathological evidence of distant metastases (M1).

History of prior chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 55 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if newer, more precise radiation treatments are effective and safe.

Who is the study for?

This trial is for men with prostate cancer that hasn't spread to other parts of the body. They must have a specific Gleason score, which measures cancer aggressiveness, and no history of chemotherapy or radiation in the pelvic area. Participants need to be able to perform daily activities without significant assistance (Karnofsky Performance Scale > 70).

What is being tested?

The study tests high-dose radiation therapy targeting lymph nodes using advanced technologies called Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT), aiming for precise delivery to improve treatment outcomes.

What are the potential side effects?

Potential side effects include skin changes in treated areas, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is at an early stage but has a high risk of spreading, or it's more advanced but hasn't spread to other parts.

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I am able to care for myself and perform normal activities with minimal assistance.

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My prostate cancer has been graded with a Gleason score.

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My prostate cancer is confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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I have had chemotherapy in the past.

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I am under 18 years old.

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I have had major surgery for prostate cancer.

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I have had radiation therapy in the pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 55 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~55 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline PSA level

Secondary study objectives

PSA level

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IMRT & IGRT Radiation TherapyExperimental Treatment1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 9Eligibility criteria met