NCT07182279RecruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 14 Nov 2026
- Lead sponsor
- The Methodist Hospital Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT07182279
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 29
- From 1 Aug 2025 to the primary completion date, 14 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior pelvic radiation therapy.
- History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
Other illness
- Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
Other
- Declared high-risk for anesthesia by attending cardiologist, or other physician.
- Prostate gland \>70 cc as assessed by MRI or TRUS.
- Baseline IPSS \>15 with medical optimization.
- Unwilling or unable to comply with the study protocol.
- \-
Who the study is looking for
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
- 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.
- Subjects must freely sign informed consent to enroll in the study.
- Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI.
- Age ≥ 40
- 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.
- 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.
- Subjects must not have had prior androgen deprivation therapy in the past 6 months.
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.