Actively Recruiting
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
Led by The Methodist Hospital Research Institute · Updated on 2026-03-09
29
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed adenocarcinoma of the prostate
- Negative bone scan and CT scan or PSMA-PET showing no nodal or metastatic disease
- Presence of at least one risk factor: PSA 2, Gleason score 8, clinical or radiographic stage 3a, or at least two of the following: PSA 10-19.9, Gleason score 4+3, clinical stage T2b/T2c, 50% positive biopsy cores
- Signed informed consent
- Medically fit to undergo surgery and HDR-B as assessed by the principal investigator
- Age 40 years or older
- ECOG Performance Status of 0 or 1
- No prior invasive malignancy in the past 3 years except non-melanomatous skin cancer unless disease free for at least 2 years; carcinoma in-situ of bladder or head and neck region allowed
- No prior androgen deprivation therapy within 6 months
You will not qualify if you...
- Presence of metastatic disease on bone scan, CT, MRI of pelvis, or PSMA-PET
- High-risk for anesthesia as determined by cardiologist or other physician
- History of prior pelvic radiation therapy
- Prostate gland volume greater than 70 cc assessed by MRI or TRUS
- Baseline International Prostate Symptom Score (IPSS) greater than 15 despite medical treatment
- Androgen deprivation therapy within past 6 months except finasteride discontinued more than 3 months prior
- Unwilling or unable to comply with study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
V
Vivian MacDonnell, CCRP
CONTACT
A
Andrew Fararch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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