Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Androgen Deprivation Therapy (ADT); Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nina Yang, RN; Phone Number: 646-830-4743; Email: Nina.Yang@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Gleason score 6 or 7 in the absence of PSA >20 ng/mL
• PSA >40 ng/mL
• Prior or concurrent androgen deprivation therapy for prostate cancer of >3 months duration
• High Risk ARTERA scores
• MRI findings: suspicious nodal metastases
• Evidence of regional lymphadenopathy or metastatic disease on MRI/CT or PSMA PET scan
• Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
• Contra-indications to receiving gadolinium contrast
• KPS < 80
• Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T4, or N1 disease or bone disease
• Prior treatment for prostate cancer, including history of chemotherapy or surgery for prostate cancer (except for prior [transurethral resection of prostate] TURP or greenlight [photo selective 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
• IPSS > 22
• Currently on any ARPis (including but not limited to: enzalutamide, apalutamide, darolutamide, or abiraterone)
• Prior pharmacologic androgen deprivation therapy (ADT) for prostate cancer is permitted under the following (2) conditions: 1) Participants meeting this criterion will be assigned to a separate stratum within each primary treatment cohort. 2) Patients remain eligible for enrollment provided they have received no more than 3 months of ADT in total, regardless of whether ADT was initiated before screening or registration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Androgen Deprivation Therapy (ADT); ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.; Other Names: Leuprolide; Degarelix; Relugolix; Radiation: Radiotherapy; Dose-escalated radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-Year Cumulative Incidence of Distant Metastases	Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease.	Up to Year 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant Metastasis-Free Survival (DMFS)	Defined as the time from study enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.	Up to Year 5
Time to Biochemical Failure	Time to biochemical failure will be measured from study enrollment to the date when the Phoenix criterion (PSA nadir + 2 ng/mL) is first met.	Up to Year 5
Overall Survival (OS)	Defined as the time from study enrollment to death from any cause.	Up to Year 5
Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score	26-item survey assessing prostate cancer-related symptom domains. Each item is rated on a Likert score. The raw score is the sum of responses and is converted to a standard score from 0-100, where higher scores indicate greater quality of life.	Baseline, Year 2
Change in International Prostate Symptom Score (IPSS) Score	7-item assessment of the severity of lower urinary tract symptoms linked to benign prostatic hyperplasia (BPH). Each item is rated on a Likert scale. The total score is the sum of responses and ranges from 0-35; lower scores indicate milder symptoms.	Baseline, Year 2
Change in Short-Form-12 (SF-12) Score	12-item assessment of health and quality of life. Each item is rated on a Likert scale. The raw score is the sum of responses and is converted to a standard score between 0-100; higher scores indicate better quality of life.	Baseline, Year 2

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Michael Zelefsky, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: high-risk prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Gonadotropin-Releasing Hormone; Leuprolide; Androgen Antagonists; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; relugolix; Radiotherapy
• Other Study ID Numbers: 26-00056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared with researchers who provide a methodologically sound proposal immediately following publication. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers must provide a methodologically sound proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes