Recruiting
Phase 2

ADT with Radiotherapy

Sponsor:

NYU Langone Health

Code:

NCT07801664

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Androgen Deprivation Therapy (ADT)

Radiotherapy

Study Details

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

Study ID

NCT07801664

Start date

Aug 6, 2026

Status verified date

Aug, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Androgen Deprivation Therapy (ADT)

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

Radiotherapy

Dose-escalated radiotherapy.

Primary outcome measure

  • 5-Year Cumulative Incidence of Distant Metastases [ Time Frame: Up to Year 5 ]

Central Contacts and Locations

Central contacts

Nina Yang, RN

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • high-risk prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-09-03.