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

Trial Title: ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

NCT ID: NCT06397703

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Leuprolide
Relugolix

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Leuprolide, Degarelix or Relugolix
Description: Patients assigned to the androgen deprivation therapy (ADT) arm will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.
Arm group label: ADT with SBRT

Intervention type: Radiation
Intervention name: Stereotactic body radiation therapy/radiosurgery (SBRT)
Description: SBRT will be directed to the prostate and delivered with a prescription dose of 40 Gy in 5 fractions prescribed to the 95% isodose line encompassing the planning target volume. Inter-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions.
Arm group label: ADT with SBRT
Arm group label: SBRT Alone

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.

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NYU Langone Health

Address:
City: New York
Zip: 10016
Country: United States

Status: Recruiting

Start date: April 16, 2024

Completion date: April 16, 2028

Lead sponsor:
Agency: NYU Langone Health
Agency class: Other

Source: NYU Langone Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06397703