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

NCT ID: NCT07182279

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-11-14

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.

Detailed Description

Approximately, 29 cancer patients will be enrolled. Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.

Patients with HR-PCa who are in the upper tercile of Decipher genomic risk (≥0.85) or have pathologically node-positive disease after lymph node dissection will receive 3 months of adjuvant AAB beginning two months post-RALP, as this is SOC for this type of patient. Node positive patients will also receive adjuvant pelvic radiation as this is SOC for this type of patient.

The primary objectives of the study will be to assess the feasibility and safety of adding HDR-B prior to RALP for patients with newly diagnosed HR-PCa and to measure per-protocol treatment compliance.

Patients will be on the study for a total of up to 27 months, including 2-3 months on active study intervention (HDR-B with RALP 4-8 weeks post HDR-B) and potentially an additional 3 months (AAB).

Study follow-ups will be performed per-protocol for up to 2 years after surgery.

Conditions

Prostate Cancer (Adenocarcinoma)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decipher < 0.85

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

Group Type: ACTIVE_COMPARATOR

Brachytherapy

Intervention Type: 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.

Decipher ≥0.85 with AAB

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.

Group Type: ACTIVE_COMPARATOR

Brachytherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Brachytherapy pre surgery

Eligibility Criteria

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&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.

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 &amp;gt;70 cc as assessed by MRI or TRUS.

5. Baseline IPSS &amp;gt;15 with medical optimization.

6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued &amp;gt; 3 mo. prior to enrollment).

7. Unwilling or unable to comply with the study protocol.

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• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Andrew Farach

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Farach, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Reseach Institute

Locations

Houston Methodist

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vivian MacDonnell, CCRP

Role: CONTACT

vmmacdonnell@houstonmethodist.org

713-441-8113

Andrew Fararch, MD

Role: CONTACT

amfarach@houstonmethodist.org

713-441-4800

Facility Contacts

Vivian MacDonnell, CCRP

Role: primary

Other Identifiers

Pro00038251

Identifier Type: -

Identifier Source: org_study_id