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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 9, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called stereotactic body radiation therapy (SBRT) for men with unfavorable intermediate-risk prostate cancer. The goal is to see if SBRT alone, without additional hormone therapy (known as androgen deprivation therapy or ADT), can effectively prevent the cancer from returning or spreading. Researchers will also be examining a specific genomic test, called the Decipher test, to help identify which patients might need more extensive radiation treatment.

To participate in this study, men aged 18 and older must have a confirmed diagnosis of prostate cancer within the last year and meet certain criteria related to their cancer's characteristics. This includes having specific scores and features that indicate a higher risk. Participants can expect to receive SBRT treatment and will be monitored closely for safety and effectiveness throughout the trial. It's important to note that individuals with certain advanced stages of cancer or prior treatments may not be eligible to join.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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)
• 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 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