Study on Short-Term Hormone Therapy and Radiation for High-Risk Prostate Cancer with Low/Intermediate ARTERA Scores
Sponsor: NYU Langone Health
Sponsor score: 40
ClinicalTrials ID:NCT07801664
This clinical trial is exploring the use of a 6-month hormone therapy combined with advanced radiation techniques to treat high-risk prostate cancer patients who have low or intermediate ARTERA scores.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to determine if a short course of hormone therapy, known as Androgen Deprivation Therapy (ADT), along with increased doses of radiation, can effectively treat high-risk prostate cancer in patients with lower ARTERA scores. Participants will receive one of several advanced radiation treatments, which may include SBRT with or without an additional brachytherapy boost.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form.
- Male participants aged 18 or older.
- Diagnosed with prostate cancer that meets at least one high-risk criteria, such as a Gleason score of 8-10, a PSA level over 20 up to 40 ng/ml, or MRI stage T1-T3 without nodal involvement.
- No signs of cancer spread to lymph nodes on initial scans.
- Low or intermediate ARTERA AI scores.
- Serum testosterone level of at least 120 ng/dL before starting ADT.
- At least 4 weeks since any major surgery.
- Good overall health with a Karnofsky Performance Status over 80.
- Prostate size less than 90 cc.
- MRI may show some cancer spread beyond the prostate capsule.
- International Prostate Symptom Score (IPSS) less than 22.
- Must meet all MRI screening criteria and agree to complete the MRI screening form.
Exclusion Criteria
- Gleason score of 6 or 7 without a PSA over 20 ng/mL.
- PSA level over 40 ng/mL.
- Previous or ongoing hormone therapy for prostate cancer lasting more than 3 months.
- High-risk ARTERA scores.
- MRI shows suspicious lymph node involvement.
- Evidence of cancer spread to lymph nodes or other areas on scans.
- Metal implants in the pelvis that could affect MRI quality.
- Cannot receive gadolinium contrast.
- Karnofsky Performance Status below 80.
- MRI or CT shows advanced cancer spread (T4, N1, or bone disease).
- Previous prostate cancer treatments, except for certain prostate surgeries.
- History of another cancer within the last 2 years, except for certain skin cancers or cancers in remission.
- IPSS score over 22.
- Currently taking certain prostate cancer medications (e.g., enzalutamide, apalutamide).
- Previous hormone therapy for prostate cancer is allowed if it was less than 3 months total.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NYU Langone Health | 10016 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
