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

NCT07801664 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 26-00056
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

high-risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Distant Metastasis-Free Survival (DMFS)

  Up to Year 5

• Time to Biochemical Failure

  Up to Year 5

• Overall Survival (OS)

  Up to Year 5

• Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score

  Baseline, Year 2

• Change in International Prostate Symptom Score (IPSS) Score

  Baseline, Year 2

Study Arms (1)

High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores

EXPERIMENTAL

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); Radiation: Radiotherapy

Interventions

Androgen Deprivation Therapy (ADT) DRUG

ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.

Also known as: Degarelix, Leuprolide, Relugolix

High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores

Radiotherapy RADIATION

Dose-escalated radiotherapy.

High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Leuprolide; relugolix; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Officials

• Michael Zelefsky, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Yang, RN

CONTACT

646-830-4743; Nina.Yang@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)