RecruitingPhase 1Phase 2NCT07182279

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)

Sponsor

The Methodist Hospital Research Institute

Enrollment

29 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Adenocarcinoma)

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

Sex: MALEMin Age: 40 Years

Inclusion Criteria13

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\&#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.
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.

Exclusion Criteria8

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

DRUGBrachytherapy

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.