Prostate CancerPhase 2NCT06397703
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
A Phase 2 study testing Leuprolide, Degarelix or Relugolix and Stereotactic body radiation therapy/radiosurgery (SBRT) in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. 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?
- Leuprolide, Degarelix or Relugolix and Stereotactic body radiation therapy/radiosurgery (SBRT)
- 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
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 16 Apr 2031
- 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
- Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)
- Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
- Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
- At least 4 weeks must have elapsed from major surgery
- Karnofsky Performance Scale (KPS) ≥ 80%
- Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on CT scan if MRI is not available
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- IPSS ≤ 20
- Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable
- Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
- Adequate renal function with serum creatinine less than or equal to 1.5 x ULN
- Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value > 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value > 9 g/dL with blood transfusions are allowed).
Who cannot join
- CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective 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
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 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer
For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide, Degarelix or Relugolix, Stereotactic body radiation therapy/radiosurgery (SBRT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide, Degarelix or RelugolixDrug
Patients assigned to the androgen deprivation therapy (ADT) arm will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.
Stereotactic body radiation therapy/radiosurgery (SBRT)Radiation
SBRT will be directed to the prostate and delivered with a prescription dose of 40 Gy in 5 fractions prescribed to the 95% isodose line encompassing the planning target volume. Intra-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions.
| Study group | Role | What they receive |
|---|---|---|
| ADT with SBRT | Experimental | The ADT patients will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills. After three months have elapsed, these patients as per routine will undergo SBRT. SBRT comprises stereotactic, ultra-fractionated radiotherapy every other day for five total treatments. Receives: Drug: Leuprolide, Degarelix or Relugolix; Radiation: Stereotactic body radiation therapy/radiosurgery (SBRT) |
| SBRT Alone | Active comparator | Participants treated with SBRT alone (standard of care) will be administered stereotactic, ultra-fractionated radiotherapy every other day for five total treatments. Receives: Radiation: Stereotactic body radiation therapy/radiosurgery (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.
Measured: Up to Year 5
Secondary outcomes (7)
Incidence of Biochemical Failure
Biochemical failure recurrence will be determined according to the established Phoenix criteria of 2 ng/nl elevation of the prostate specific antigen (PSA) nadir level (nadir + 2 definition).
Measured: Up to Year 5
Incidence of Distant Metastases
Number of distant metastases observed over the course of the study.
Measured: Up to Year 5
Overall Survival
Defined as the length of time from the date of first treatment until death.
Measured: Up to Year 5
Number of Positive Post-Treatment Biopsies
Measured: Year 2 Post-Treatment (Month 24-30)
Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26)
26-item assessment of prostate cancer symptoms. Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 26 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores are averaged to derive a quality of life score, ranging from 0-100.
Measured: Baseline, Year 2
Change in International Prostatism Symptom Score (IPSS)
7-item questionnaire of benign prostatic hyperplasia (BPH) symptoms. Each item is rated on a scale from 0 (not at all) to 5 (almost always). The total score is the sum of responses and ranges from 0 to 35; higher scores indicate greater BPH symptomology.
Measured: Baseline, Year 2
Change in 12-Item Short Form Health Survey (SF-12) Score
The SF-12 is a 12-item assessment of the impact of health on an individual's everyday life. The total score is the sum of each item and is standardized; the total score ranges from 0 to 100, with higher scores indicated better physical and mental health functioning.
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 May 2024
- Study start16 Apr 2024
- Primary completion16 Apr 2030 (estimated)
- Study completion16 Apr 2031 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zelefsky, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397703
- Sponsor's protocol ID
- 23-01267
- Status last verified
- Jan 2026
- First submitted
- 29 Apr 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD access will be limited to study team members who are IRB approved and listed on the delegation log.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06397703
- Acronym / sponsor ID
- 23-01267
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 16 Apr 2030 (estimated)
- Study completion
- 16 Apr 2031 (estimated)
- First posted
- 3 May 2024 (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, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT with SBRT | Experimental | Drug: Leuprolide, Degarelix or Relugolix, Radiation: Stereotactic body radiation therapy/radiosurgery (SBRT)The ADT patients will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills. After three months have elapsed, these patients as per routine will undergo SBRT. SBRT comprises stereotactic, ultra-fractionated radiotherapy every other day for five total treatments. |
| SBRT Alone | Active comparator | Radiation: Stereotactic body radiation therapy/radiosurgery (SBRT)Participants treated with SBRT alone (standard of care) will be administered stereotactic, ultra-fractionated radiotherapy every other day for five total treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)
- Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
- Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
- At least 4 weeks must have elapsed from major surgery
- Karnofsky Performance Scale (KPS) ≥ 80%
Key exclusion criteria (5 listed)
- CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective 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
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 |
|---|---|---|
| Leuprolide, Degarelix or RelugolixPatients assigned to the androgen deprivation therapy (ADT) arm will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions. | Drug | ADT with SBRT |
| Stereotactic body radiation therapy/radiosurgery (SBRT)SBRT will be directed to the prostate and delivered with a prescription dose of 40 Gy in 5 fractions prescribed to the 95% isodose line encompassing the planning target volume. Intra-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions. | Radiation | ADT with SBRT, SBRT Alone |
Primary outcome
Disease-Free Survival
Time frame: Up to Year 5
Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.
7 secondary outcomes
Incidence of Biochemical Failure
Time frame: Up to Year 5
Incidence of Distant Metastases
Time frame: Up to Year 5
Overall Survival
Time frame: Up to Year 5
Number of Positive Post-Treatment Biopsies
Time frame: Year 2 Post-Treatment (Month 24-30)
Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26)
Time frame: Baseline, Year 2
Change in International Prostatism Symptom Score (IPSS)
Time frame: Baseline, Year 2
Change in 12-Item Short Form Health Survey (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 28 Jan 2026.
- Individual participant dataSharing planned: No. De-identified IPD access will be limited to study team members who are IRB approved and listed on the delegation log.
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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 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 Leuprolide, Degarelix or Relugolix and Stereotactic body radiation therapy/radiosurgery (SBRT) 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 11 inclusion and 5 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 28 Jan 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 Dayna Leis, RN (347-266-2630, Dayna.Leis@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (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 28 Jan 2026.