High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)
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|ClinicalTrials.gov Identifier: NCT02177292|
Recruitment Status : Recruiting
First Posted : June 27, 2014
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Radiation Therapy||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||June 23, 2010|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2060|
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 Name: Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
- Biochemical control [ Time Frame: 3 years after registration of the last subject. ]The primary goal of this study is to evaluate biochemical control assessed by PSA level.
- Incidence of adverse events as assessed by Common Toxicity Criteria of Adverse Events. [ Time Frame: 3 years after registration of the last subject. ]The time to the occurrence of severe late GU/GI toxicity is defined as the time interval from the tenth month after start of protocol treatment to the date of death.
- Metastasis free survival [ Time Frame: 3 years after registration of the last subject. ]Metastasis free survival in patients receiving dose escalation IG-IMRT (image-guided IMRT) to the pelvic lymph nodes with a simultaneous integrated boost to the prostate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177292
|Contact: Colleen A Lawton, MDfirstname.lastname@example.org|
|Principal Investigator:||Colleen A Lawton, MD||Medical College of Wisconsin|