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Site for Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)

The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu or 717-531-0003, ext=289630
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03367702
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Inclusion Criteria:
ECOG Performance Status 0-1 60 days prior to registration
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older
Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease. No nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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Location
Hershey, PA