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

Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer (NCT07182279) is a Phase 1 / Phase 2 interventional studying Prostate Cancer (Adenocarcinoma), sponsored by The Methodist Hospital Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Prostate Cancer (Adenocarcinoma), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 29 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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\&#39; 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. Who Should NOT Join This Trial: 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 \&gt;70 cc as assessed by MRI or TRUS. 5. Baseline IPSS \&gt;15 with medical optimization. 6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \&gt; 3 mo. prior to enrollment). 7. Unwilling or unable to comply with the study protocol. \- Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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\&#39; 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 \&gt;70 cc as assessed by MRI or TRUS. 5. Baseline IPSS \&gt;15 with medical optimization. 6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \&gt; 3 mo. prior to enrollment). 7. Unwilling or unable to comply with the study protocol. \-

Treatments Being Tested

DRUG

Brachytherapy

All patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Houston Methodist

Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07182279), the sponsor (The Methodist Hospital Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07182279 clinical trial studying?

Who can participate in NCT07182279?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07182279?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07182279. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07182279. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.