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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Houston Methodist
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Andrew Farach, MD — The Methodist Hospital Reseach Institute
• Study coordinator: Vivian MacDonnell, CCRP
• Email: vmmacdonnell@houstonmethodist.org
• Phone: 713-441-8113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.