High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

Prostate Cancer Clinical Trial

— SIB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02177292
• Other study ID #: PRO00013374
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2010
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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:

1. allow a higher daily dose of radiation to the tumor and pelvic nodes

2. avoid nearby normal tissue and organs like the rectum and bladder

3. prevent the cancer from spreading or coming back

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiation Therapy
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).

Locations

Country	Name	City	State
United States	Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	4 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	7 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	10 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	13 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	16 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	19 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	22 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	25 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	31 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	37 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	43 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	49 months
Primary	Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	55 months