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

NCT07182279 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro00038251
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

high risk prostate cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP

  up to two years post RALP

• Treatment Completion

  to assess rate of treatment completion per protocol

  up to two years post RALP

Secondary Outcomes (7)

• Change From Baseline in International Prostate Symptom Score (IPSS)

  Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)

• Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC-26) Score

  Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)

• Change in Prostate-Specific Antigen (PSA)

  Baseline and within 2 weeks prior to RALP (4-8 weeks after HDR brachytherapy)

• Radiologic Tumor Response on Multiparametric MRI (mpMRI)

  Baseline and within 2 weeks prior to RALP

• Pathologic Response in Prostatectomy Specimen

  At RALP (4-8 weeks after HDR brachytherapy)

Study Arms (2)

Decipher < 0.85

ACTIVE COMPARATOR

Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.

Drug: Brachytherapy

Decipher ≥0.85 with AAB

ACTIVE COMPARATOR

Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. In addition, patients with high genomic risk (≥0.85) will receive AAB for 12 weeks in the adjuvant setting beginning 8 weeks post RALP. Patients will receive an androgen receptor inhibitor per treating physician discretion (darolutamide 600 mg PO BID, enzalutamide 160 mg PO QD, apalutamide 240 mg PO QD, or bicalutamide 50 mg PO QD). In addition, patients will receive either a GnRH antagonist (relugolix 360 mg PO x 1 day followed by 120 mg PO QD) or a GnRH agonist (leuprolide 22.5 mg SC once or goserelin 10.8 mg SC once). Pathologically node positive patients will receive adjuvant pelvic radiation therapy as is SOC once the patient has recovered from surgery.

Drug: Brachytherapy

Interventions

Brachytherapy DRUG

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.

Also known as: Brachytherapy pre surgery

Decipher < 0.85; Decipher ≥0.85 with AAB

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\&amp;#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.

You may not qualify if:

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Andrew Farach, MD

  The Methodist Hospital Reseach Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian MacDonnell, CCRP

CONTACT

713-441-8113; vmmacdonnell@houstonmethodist.org

Andrew Fararch, MD

CONTACT

713-441-4800; amfarach@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 19, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)