A Phase II Prospective 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer
Summary
For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 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 treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.
Arms & interventions
- DrugLeuprolide, Degarelix or Relugolix
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.
- RadiationStereotactic body radiation therapy/radiosurgery (SBRT)
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. Intra-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions.
Outcome measures
Primary
Disease-Free Survival
Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.
Time frame: Up to Year 5
Secondary
Incidence of Biochemical Failure
Time frame: Up to Year 5
Incidence of Distant Metastases
Time frame: Up to Year 5
Overall Survival
Time frame: Up to Year 5
Number of Positive Post-Treatment Biopsies
Time frame: Year 2 Post-Treatment (Month 24-30)
Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26)
Time frame: Baseline, Year 2
Change in International Prostatism Symptom Score (IPSS)
Time frame: Baseline, Year 2
Change in 12-Item Short Form Health Survey (SF-12) Score
Time frame: Baseline, Year 2
Eligibility criteria
Study locations (1)
NYU Langone Health
New York, New York, 10016