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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06397703
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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 Details

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.

Key Dates

Start date
Apr 16, 2024
Status verified
Jan 2026
Primary completion
Apr 16, 2030
Completion
Apr 16, 2031

Study Design

Enrollment
392 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADT with 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.
  • Active Comparator: SBRT Alone
    Participants treated with SBRT alone (standard of care) will be administered stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.

Primary Outcome Measure

Disease-Free Survival [ Time Frame: Up to Year 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
NYU Langone Health· New York, NY

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