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

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02177292
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 197.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Radiation Therapy	N/A

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:

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 23, 2010
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMRT & IGRT Radiation Therapy 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).	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).; Other Names: Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Outcome Measures

Primary Outcome Measures

1. PSA level at baseline [Baseline]

   PSA level in blood is measured in units of nanograms per milliliter.

Secondary Outcome Measures

1. PSA level [4 months]

   PSA level in blood is measured in units of nanograms per milliliter.

2. PSA level [7 months]

   PSA level in blood is measured in units of nanograms per milliliter.

3. PSA level [10 months]

   PSA level in blood is measured in units of nanograms per milliliter.

4. PSA level [13 months]

   PSA level in blood is measured in units of nanograms per milliliter.

5. PSA level [16 months]

   PSA level in blood is measured in units of nanograms per milliliter.

6. PSA level [19 months]

   PSA level in blood is measured in units of nanograms per milliliter.

7. PSA level [22 months]

   PSA level in blood is measured in units of nanograms per milliliter.

8. PSA level [25 months]

   PSA level in blood is measured in units of nanograms per milliliter.

9. PSA level [31 months]

   PSA level in blood is measured in units of nanograms per milliliter.

10. PSA level [37 months]

    PSA level in blood is measured in units of nanograms per milliliter.

11. PSA level [43 months]

    PSA level in blood is measured in units of nanograms per milliliter.

12. PSA level [49 months]

    PSA level in blood is measured in units of nanograms per milliliter.

13. PSA level [55 months]

    PSA level in blood is measured in units of nanograms per milliliter.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Froedtert Hospital	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin

Investigators

• Principal Investigator: Colleen A Lawton, MD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

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. Epub 2007 Jun 4.

• Responsible Party: Colleen A. Lawton, Professor, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT02177292
• Other Study ID Numbers: Prostate Cancer
• First Posted: Jun 27, 2014
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 10, 2022