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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexMale
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

relugolix. An orally available, non-peptide gonadotropin-releasing hormone (GnRH or luteinizing hormone-releasing hormone (LHRH)) antagonist, with potential antineoplastic activity. Relugolix competitively binds to and blocks the GnRH receptor in the anterior pituitary gland, which both prevents GnRH binding to the GnRH receptor and inhibits the secretion and release of both luteinizing hormone (LH) and follicle stimulating hormone (FSH). In males, the inhibition of LH secretion prevents the release of testosterone from Leydig cells in the testes. Since testosterone is required to sustain prostate growth, reducing testosterone levels may inhibit hormone-dependent prostate cancer cell proliferation. NCI Drug Dictionary

degarelix. A long-acting, synthetic peptide with gonadotrophin-releasing hormone (GnRH) antagonistic properties. Degarelix targets and blocks GnRH receptors located on the surfaces of gonadotroph cells in the anterior pituitary, thereby reducing secretion of luteinizing hormone (LH) by pituitary gonadotroph cells and so decreasing testosterone production by interstitial (Leydig) cells in the testes. NCI Drug Dictionary

leuprolide acetate. The acetate salt of a synthetic nonapeptide analogue of gonadotropin-releasing hormone. Leuprolide binds to and activates gonadotropin-releasing hormone (GnRH) receptors. Continuous, prolonged administration of leuprolide in males results in pituitary GnRH receptor desensitization and inhibition of pituitary secretion of follicle stimulating hormone (FSH) and luteinizing hormone (LH), leading to a significant decline in testosterone production; in females, prolonged administration results in a decrease in estradiol production. This agent reduces testosterone production to castration levels and may inhibit androgen receptor-positive tumor progression. NCI Drug Dictionary

Treatments listed in the registry

• 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.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• radiation: Part of the study plan

Main goals

• 5-Year Cumulative Incidence of Distant Metastases (Up to Year 5)

Other goals

• Distant Metastasis-Free Survival (DMFS)
• Time to Biochemical Failure
• Overall Survival (OS)
• Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score
• Change in International Prostate Symptom Score (IPSS) Score
• Change in Short-Form-12 (SF-12) Score

Planned enrollment: 90 (estimated).

• NYU Langone Health, New York, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07801664
• NCI Drug Dictionary: C114498
• NCI Drug Dictionary: C48385
• NCI Drug Dictionary: C1319

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 2, 2026. Public record; not medical advice.