Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate… (NCT07182279) | Clinical Trial Compass
RecruitingPhase 1/2
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
United States29 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range40 Years
SexMALE
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
✕. Declared high-risk for anesthesia by attending cardiologist, or other physician.
✕. History of prior pelvic radiation therapy.
✕. Prostate gland \>70 cc as assessed by MRI or TRUS.