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NCT07182279

Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: 4 to 7v2
  2. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Incidence of Adverse Events
Timeframe: up to two years post RALP
Treatment Completion
Timeframe: up to two years post RALP

Secondary (7)

Change From Baseline in International Prostate Symptom Score (IPSS)
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC-26) Score
Change in Prostate-Specific Antigen (PSA)
Radiologic Tumor Response on Multiparametric MRI (mpMRI)
Pathologic Response in Prostatectomy Specimen
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Biochemical recurrence
Regional and distant metastasis

Arms and interventions

Decipher < 0.85Active comparator

Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.

Decipher ≥0.85 with AABActive comparator

Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. In addition, patients with high genomic risk (≥0.85) will receive AAB for 12 weeks in the adjuvant setting beginning 8 weeks post RALP. Patients will receive an androgen receptor inhibitor per treating physician discretion (darolutamide 600 mg PO BID, enzalutamide 160 mg PO QD, apalutamide 240 mg PO QD, or bicalutamide 50 mg PO QD). In addition, patients will receive either a GnRH antagonist (relugolix 360 mg PO x 1 day followed by 120 mg PO QD) or a GnRH agonist (leuprolide 22.5 mg SC once or goserelin 10.8 mg SC once). Pathologically node positive patients will receive adjuvant pelvic radiation therapy as is SOC once the patient has recovered from surgery.

Drugs: Brachytherapy

Sites

1 site in 1 country

  • Houston MethodistHouston, Texas, United States