Clinical trial NCT02177292: High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline PSA level
timeFrame: 4 months
measure: Change from baseline PSA level
timeFrame: 7 months
measure: Change from baseline PSA level
timeFrame: 10 months
measure: Change from baseline PSA level
timeFrame: 13 months
measure: Change from baseline PSA level
timeFrame: 16 months
measure: Change from baseline PSA level
timeFrame: 19 months
measure: Change from baseline PSA level
timeFrame: 22 months
measure: Change from baseline PSA level
timeFrame: 25 months
measure: Change from baseline PSA level
timeFrame: 31 months
measure: Change from baseline PSA level
timeFrame: 37 months
measure: Change from baseline PSA level
timeFrame: 43 months
measure: Change from baseline PSA level
timeFrame: 49 months
measure: Change from baseline PSA level
timeFrame: 55 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: William Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.