Prostate Cancer Clinical Trial

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

Summary

For this proposed Phase III study, unfavorable intermediate risk prostate cancer patients will be randomized to receive 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient randomized and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.

View Eligibility Criteria

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 randomization.
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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

392

Study ID:

NCT06397703

Recruitment Status:

Recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

392

Study ID:

NCT06397703

Recruitment Status:

Recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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