NCT07801664 · NYU Langone Health
Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer
What this study is about
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.
View original scientific 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
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.
RADIATION
Radiotherapy
Dose-escalated radiotherapy.
Primary outcome measures
5-Year Cumulative Incidence of Distant Metastases
Time frame: Up to Year 5
Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2026 · Source of record for eligibility and locations