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HDR Brachytherapy Before Prostate Surgery for High-Risk Prostate Cancer

This study is looking at whether adding a type of radiation therapy called High Dose Rate Brachytherapy (HDR-B) before surgery (Radical Prostatectomy, RALP) is safe and effective for men with high-risk prostate cancer. All participants will receive a single HDR-B treatment 4-8 weeks before their RALP surgery. Some patients with very high genomic risk or cancer in their lymph nodes will also receive additional hormone therapy (adjuvant AAB) after surgery. The study aims to see how well patients tolerate this treatment and if they complete all parts of it. You may be able to join if you are a man aged 40 or older with biopsy-confirmed prostate cancer that has not spread, and have certain risk factors like a high PSA or Gleason score.

Study design
This is an interventional study, meaning participants will receive a specific treatment. Approximately 29 men will be enrolled.
What's involved
You would be on the study for up to 27 months, including 2-3 months for the HDR-B and RALP, and potentially an additional 3 months for hormone therapy.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up appointments for up to 2 years after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07182279

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

Recruiting
PHASE1Ages 40+InterventionalTreatment
The Methodist Hospital Research Institute
~29 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Brachytherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over up to two years post RALP
+1 more outcome measured

Conditions

Prostate Cancer (Adenocarcinoma)

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Andrew Farach, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Reseach Institute

Who to contact

Vivian MacDonnell, CCRP
[email protected]
713-441-8113
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PSA ≥20 and/or
Gleason score ≥8 and/or
Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or
At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 4+3, clinical stage = T2b/T2c, ≥50% positive biopsy cores. 4. Subjects must freely sign informed consent to enroll in the study. 5. Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI. 6. Age ≥ 40 7. ECOG Performance Status (performance status is an attempt to quantify cancer patients\' general well-being and activities of daily life, scores range from 0 to 5 where 0 represents perfect health and 5 represents death): 0-1. 8. No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible. 9. Subjects must not have had prior androgen deprivation therapy in the past 6 months.

What this trial measures

  • Incidence of Adverse Eventsup to two years post RALP

    to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP

  • Treatment Completionup to two years post RALP

    to assess rate of treatment completion per protocol