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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: NYU Langone Health • ClinicalTrials.gov ID: NCT07801664

Registry updated: 2026-09-03
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Description

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.

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.
  • Radiotherapy (Radiation)
    Dose-escalated radiotherapy.

Eligibility 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.

Conditions

Prostate Cancer

Locations

  • NYU Langone Health — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record