A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
≥ 50% biopsy cores positive
Two or more of the following risk factors:
* Grade Group 2 or 3
* cT2b-T2c
* 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 ≤ 20
Age ≥ 18
KPS ≥ 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)
You may not be if
Radiographic T3-T4 detected on staging mpMRI
°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
