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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Men only

Short Course ADT with Dose-Escalated Radiotherapy for High-Risk Prostate Cancer

Official title: 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

Run by NYU Langone Health · NCT07801664 · Data updated 2026-11-12

High-risk prostate cancer patients with low/intermediate ARTERA scores will receive 6 months of androgen deprivation therapy along with dose-escalated radiotherapy to the prostate and nodes to see if this combination works.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment90 (estimated)
SponsorNYU Langone Health
Academic / other
Drugs / interventionschemotherapy
Locations1 site (New York, New York)
StatusRecruiting
StartedAugust 6, 2026
Main results expectedAugust 1, 2028
Study endsAugust 1, 2029
Registry record updatedSeptember 3, 2026
Trial IDNCT07801664 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with biopsy-proven high-risk prostate cancer, low/intermediate ARTERA scores, no nodal metastases, MRI staging compliant, and adequate organ function.

Probably not a fit

Patients with nodal involvement, higher ARTERA scores, or contraindications to ADT or radiotherapy may be less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 2 trial tests whether 6 months of androgen deprivation therapy combined with dose-escalated radiotherapy—such as SBRT with or without a brachytherapy boost—can be safely delivered to patients with high-risk prostate cancer and lower ARTERA scores. Eligible participants are men 18 or older with biopsy-proven disease meeting high-risk criteria, no nodal metastases, and favorable ARTERA scores, who can undergo MRI-based assessment and consent to the study procedures. Treatment aims to personalize radiotherapy dose while administering systemic hormone therapy, with outcomes to be monitored for safety and preliminary efficacy. The study is led by NYU Langone Health and conducted at their New York site.

Why it matters

Potential benefit: If successful, the approach could improve local control while maintaining tolerability for high-risk patients.

How similar studies have gone: Prior studies in radiotherapy dose escalation and short-course ADT have shown promise in select populations, but this specific ARTERA-guided, abbreviated approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.