Trials / Recruiting
RecruitingNCT06397703
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 392 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprolide, 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. |
| RADIATION | Stereotactic 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. |
Timeline
- Start date
- 2024-04-16
- Primary completion
- 2030-04-16
- Completion
- 2031-04-16
- First posted
- 2024-05-03
- Last updated
- 2026-01-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06397703. Inclusion in this directory is not an endorsement.