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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07182279
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

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

Interventions

  • Brachytherapy — DRUG
    All patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.

Study Details

This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients. Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.

Key Dates

Start date
Aug 1, 2025
Status verified
Mar 2026
Primary completion
Nov 14, 2026
Completion
Nov 14, 2026

Study Design

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

Arms

  • Active Comparator: Decipher < 0.85
    Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.
  • Active Comparator: Decipher ≥0.85 with AAB
    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.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: up to two years post RALP ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston MethodistHoustonTexas77030
Vivian MacDonnell, CCRP
Andrew Farach, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Houston Methodist· Houston, TX

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