ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

NCT06397703 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-01267
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.

  Up to Year 5

Secondary Outcomes (7)

• Incidence of Biochemical Failure

  Up to Year 5

• Incidence of Distant Metastases

  Up to Year 5

• Overall Survival

  Up to Year 5

• Number of Positive Post-Treatment Biopsies

  Year 2 Post-Treatment (Month 24-30)

• Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26)

  Baseline, Year 2

Study Arms (2)

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.

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.

Radiation: Stereotactic body radiation therapy/radiosurgery (SBRT)

Interventions

Leuprolide, Degarelix or Relugolix DRUG

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.

ADT with SBRT

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.

ADT with SBRT; SBRT Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; relugolix; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michael Zelefsky

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dayna Leis, RN

CONTACT

347-266-2630; Dayna.Leis@nyulangone.org

Nina Yang, RN

CONTACT

646-830-4743; Nina.Yang@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): April 16, 2030
• Study Completion (Estimated): April 16, 2031
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)