Prostate Cancer Clinical Trials

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A Phase II Prospective Trial Utilizing Short Course Androgen Deprivation Therapy In Conjunction With Ultra-Hypofractionated SBRT For High Risk Nccn Prostate Cancer With Lower Risk Artera Scores

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability to understand and willingness to sign a written informed consent document

• 18 years of age or older male participants

• Biopsy proven prostate cancer meeting at least one of the following high-risk criteria: Gleason score 8-10 OR; Baseline PSA \>20 up to and including 40 ng/ml OR; Patients with Gleason score 6-7 remain eligible if the PSA criterion (\>20 ng/mL) is met OR; MRI Radiographic stage T1-T3 disease without evidence of nodal involvement

• No imaging evidence of nodal metastases on baseline MRI/ CT of the pelvis and PET-PSMA scans

• Low risk or intermediate risk ARTERA AI scores

• Serum testosterone ≥ 120 ng/dL determined prior to ADT start

• At least 4 weeks must have elapsed from major surgery

• Karnofsky Performance Status (KPS) \> 80

• Prostate size \< 90 cc

• MRI findings: Lesion may have extracapsular extension (ECE)

• International Prostate Symptom Score (IPSS) \< 22

• Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Nina Yang, RN
Nina.Yang@nyulangone.org
646-830-4743
Time Frame
Start Date: 2026-08-06
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 90
Treatments
Experimental: High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores
Patients will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov