Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Urologic Cancer
Treatment
Stereotactic Body Radiation Therapy (SBRT)
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pathologically proven diagnosis of prostate adenocarcinoma within 12 months ofenrollment
Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratificationguidelines, 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 andRelease of Health and Research Study Information (HIPAA authorization)
Exclusion
Exclusion Criteria:
- 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 hormonaltherapy
Prior pelvic radiation
Active second malignancy or past history of malignancies diagnosed within the last 2years that requires active therapy and/or in remission, with the exception ofresected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I headand neck cancer, or stage I colorectal cancer
TURP or greenlight PVP within 6 months of enrollment
History of Crohn's Disease or Ulcerative Colitis
Study Design
Connect with a study center
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memoral Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York 11553
United StatesActive - Recruiting
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