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NCT Number: NCT02177292

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

radiation therapy

Radiation

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).

Primary outcomes

  1. Change from baseline PSA level

    Time frame: 4 months

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

  2. Change from baseline PSA level

    Time frame: 7 months

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

  3. Change from baseline PSA level

    Time frame: 10 months

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

  4. Change from baseline PSA level

    Time frame: 13 months

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

  5. Change from baseline PSA level

    Time frame: 16 months

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

  6. Change from baseline PSA level

    Time frame: 19 months

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

  7. Change from baseline PSA level

    Time frame: 22 months

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

  8. Change from baseline PSA level

    Time frame: 25 months

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

  9. Change from baseline PSA level

    Time frame: 31 months

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

  10. Change from baseline PSA level

    Time frame: 37 months

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

  11. Change from baseline PSA level

    Time frame: 43 months

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

  12. Change from baseline PSA level

    Time frame: 49 months

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

  13. Change from baseline PSA level

    Time frame: 55 months

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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study 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

Acronym: SIB

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2014
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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