ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

Launched by NYU LANGONE HEALTH · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of combining two treatments—Androgen Deprivation Therapy (ADT) and Stereotactic Body Radiation Therapy (SBRT)—for men with a specific type of prostate cancer known as unfavorable intermediate risk prostate cancer. The goal is to see if adding ADT to SBRT can provide better results than using SBRT alone. Eligible participants are men aged 65 to 74 who have been diagnosed with this type of prostate cancer and meet certain health criteria. They should not have any signs of cancer spreading to other parts of the body and must have tissue samples available for additional testing.

Participants in the study will receive either the combination treatment or SBRT alone and will be monitored every six months for up to five years. They will also undergo a biopsy about two years after treatment to check for any remaining cancer cells. This trial is currently recruiting, and it aims to determine the best treatment option for men facing this challenging diagnosis. It's important for potential participants to understand the eligibility criteria and that their health will be closely monitored throughout the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores \> 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)
• • Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
• • Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
• • At least 4 weeks must have elapsed from major surgery
• • Karnofsky Performance Scale (KPS) ≥ 80%
• • Prostate size as determined on MRI to be \< 90 cc. Prostate size can be determined on CT scan if MRI is not available
• • IPSS ≤ 20
• • Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable
• • Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is \< 3 mg/dL with a predominance of indirect bilirubin
• • Adequate renal function with serum creatinine less than or equal to 1.5 x ULN
• • Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value \> 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value \> 9 g/dL with blood transfusions are allowed).
• Exclusion Criteria:
• • CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone
• • Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
• • Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed)
• • History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
• • Patients with Crohn's disease or ulcerative colitis