A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

Korábbi kezelés

• Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
• Prior pelvic radiation

Más betegség

• 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.
• 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
• History of Crohn's Disease or Ulcerative Colitis

Egyéb

• 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
• TURP or greenlight PVP within 6 months of enrollment

• 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)