Prostate CancerPhase 2NCT07801664
Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer
A Phase 2 study testing Androgen Deprivation Therapy (ADT) and Radiotherapy in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Androgen Deprivation Therapy (ADT) and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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
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
- Being tested
- Androgen Deprivation Therapy (ADT), Radiotherapy
- Keywords
- high-risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Deprivation Therapy (ADT)Drug
Also called Degarelix, Leuprolide, Relugolix
ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.
RadiotherapyRadiation
Dose-escalated radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Androgen Deprivation Therapy (ADT); Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Year 5
Secondary outcomes (6)
Distant Metastasis-Free Survival (DMFS)
Defined as the time from study enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Measured: Up to Year 5
Time to Biochemical Failure
Time to biochemical failure will be measured from study enrollment to the date when the Phoenix criterion (PSA nadir + 2 ng/mL) is first met.
Measured: Up to Year 5
Overall Survival (OS)
Defined as the time from study enrollment to death from any cause.
Measured: Up to Year 5
Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score
26-item survey assessing prostate cancer-related symptom domains. Each item is rated on a Likert score. The raw score is the sum of responses and is converted to a standard score from 0-100, where higher scores indicate greater quality of life.
Measured: Baseline, Year 2
Change in International Prostate Symptom Score (IPSS) Score
7-item assessment of the severity of lower urinary tract symptoms linked to benign prostatic hyperplasia (BPH). Each item is rated on a Likert scale. The total score is the sum of responses and ranges from 0-35; lower scores indicate milder symptoms.
Measured: Baseline, Year 2
Change in Short-Form-12 (SF-12) Score
12-item assessment of health and quality of life. Each item is rated on a Likert scale. The raw score is the sum of responses and is converted to a standard score between 0-100; higher scores indicate better quality of life.
Measured: Baseline, Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start6 Aug 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zelefsky, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801664
- Sponsor's protocol ID
- 26-00056
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared with researchers who provide a methodologically sound proposal immediately following publication. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements. 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07801664
- Acronym / sponsor ID
- 26-00056
- Conditions
- Prostate Cancer
- Keywords
- high-risk prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores | Experimental | Drug: Androgen Deprivation Therapy (ADT), Radiation: RadiotherapyPatients will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen Deprivation Therapy (ADT)Also: Degarelix, Leuprolide, RelugolixADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions. | Drug | High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores |
| RadiotherapyDose-escalated radiotherapy. | Radiation | High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores |
Primary outcome
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.
6 secondary outcomes
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to Year 5
Time to Biochemical Failure
Time frame: Up to Year 5
Overall Survival (OS)
Time frame: Up to Year 5
Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score
Time frame: Baseline, Year 2
Change in International Prostate Symptom Score (IPSS) Score
Time frame: Baseline, Year 2
Change in Short-Form-12 (SF-12) Score
Time frame: Baseline, Year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared with researchers who provide a methodologically sound proposal immediately following publication. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Zelefsky, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen Deprivation Therapy (ADT) and Radiotherapy in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Yang, RN (646-830-4743, Nina.Yang@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-Year Cumulative Incidence of Distant Metastases (time frame: Up to Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.