NCT07182279 Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
| NCT ID | NCT07182279 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-11-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 29 participants in total. It began in 2025-08-01 with a primary completion date of 2026-11-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. \-
Contact & Investigator
Andrew Farach, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Reseach Institute
Frequently Asked Questions
Who can join the NCT07182279 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07182279 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07182279 currently recruiting?
Yes, NCT07182279 is actively recruiting participants. Contact the research team at vmmacdonnell@houstonmethodist.org for enrollment information.
Where is the NCT07182279 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07182279 clinical trial?
NCT07182279 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Andrew Farach, MD at The Methodist Hospital Reseach Institute. The trial plans to enroll 29 participants.
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