High-dose brachytherapy before robotic radical prostatectomy for high-risk prostate cancer

High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)

This trial will test whether a single high-dose (15 Gy) brachytherapy treatment given 4–8 weeks before robotic prostate removal helps people with newly diagnosed, non-metastatic high-risk prostate cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 40 Years and up
• Sex: Male
• Sponsor: The Methodist Hospital Research Institute (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07182279 on ClinicalTrials.gov

What this trial studies

This Phase I/II, single-center trial will enroll about 29 men with biopsy-proven, non-metastatic high-risk prostate adenocarcinoma who are scheduled for robotic-assisted laparoscopic prostatectomy (RALP). Participants receive one 15 Gy HDR brachytherapy fraction 4–8 weeks before RALP, with follow-up for up to two years after surgery. Patients with very high Decipher genomic risk (≥0.85) or pathologically node-positive disease will receive three months of adjuvant androgen blockade beginning two months after RALP, and node-positive patients will also receive adjuvant pelvic radiation per standard of care. Primary goals are to test feasibility, safety, and adherence to the per-protocol treatment sequence.

Who should consider this trial

Good fit: Men aged 40 or older with newly diagnosed, non-metastatic high-risk prostate adenocarcinoma (e.g., PSA ≥20, Gleason ≥8, or clinical stage ≥T3a, or meeting other specified high-risk criteria), ECOG 0–1, and medically fit for both HDR brachytherapy and prostatectomy are ideal candidates.

Not a fit: Patients with metastatic disease, poor performance status (ECOG >1), or who are not candidates for surgery or brachytherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control before surgery and potentially reduce the risk of recurrence for selected high-risk patients.

How similar studies have performed: Neoadjuvant HDR brachytherapy before prostatectomy is relatively novel with only small single-center series and limited data suggesting feasibility but not yet definitive oncologic benefit.

Eligibility criteria

Inclusion Criteria:

1. Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
2. Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
3. Subjects must have one of the following risk factors:

   * 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.

Exclusion Criteria:

1. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
2. Declared high-risk for anesthesia by attending cardiologist, or other physician.
3. History of prior pelvic radiation therapy.
4. Prostate gland \>70 cc as assessed by MRI or TRUS.
5. Baseline IPSS \>15 with medical optimization.
6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
7. Unwilling or unable to comply with the study protocol.

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Where this trial is running

Houston, Texas

• Houston Methodist — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Andrew Farach, MD — The Methodist Hospital Reseach Institute
• Study coordinator: Vivian MacDonnell, CCRP

Conditions Prostate Cancer; high risk prostate cancer