Prostate Cancer Clinical Trial
A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments
Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
Gleason Score 4+3
â‰¥ 50% biopsy cores positive
Two or more of the following risk factors:
Grade Group 2 or 3
PSA 10 - 20 ng/mL
Able to undergo MRI for initial staging and MR based radiation planning
Sufficient biopsy tissue available for Decipher genomic testing
Prostate volume < 90cc
IPSS â‰¤ 20
Age â‰¥ 18
KPS â‰¥ or ECOG 0-2
Estimated life expectancy >5 years
Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
Radiographic T3-T4 detected on staging mpMRI
Â°Must be "consistent with" (>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist.
Evidence of distant metastases as determined by MRI, PET, or CT imaging
Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
Prior pelvic radiation
Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
TURP or greenlight PVP within 6 months of enrollment
History of Crohn's Disease or Ulcerative Colitis
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