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

Phase 2RecruitingNCT07182279

The Methodist Hospital Research Institute29 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer (Adenocarcinoma)

Interventions

BrachytherapyDRUG

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.

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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\&#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 \&gt;70 cc as assessed by MRI or TRUS. 5. Baseline IPSS \&gt;15 with medical optimization. 6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \&gt; 3 mo. prior to enrollment). 7. Unwilling or unable to comply with the study protocol. \-

Locations (1)

Houston Methodist

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of Adverse Events

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

Time frame: up to two years post RALP

Treatment Completion

to assess rate of treatment completion per protocol

Time frame: up to two years post RALP

Secondary Outcomes

Change From Baseline in International Prostate Symptom Score (IPSS)

Urinary health-related quality of life will be assessed using the International Prostate Symptom Score (IPSS). The IPSS questionnaire consists of 7 questions evaluating urinary symptoms. Total scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Change from baseline will be calculated at each follow-up time point.

Time frame: 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

Health-related quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26), a validated questionnaire that evaluates urinary, bowel, sexual, and hormonal domains in patients with prostate cancer. Scores range from 0 to 100, with higher scores indicating better quality of life. Change from baseline will be calculated at each follow-up time point.

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

Change in Prostate-Specific Antigen (PSA)

Clinical response will be assessed by the change in serum prostate-specific antigen (PSA) levels from baseline to immediately prior to robot-assisted laparoscopic prostatectomy (RALP).

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

Central Contacts

Vivian MacDonnell, CCRP

CONTACT

713-441-8113 vmmacdonnell@houstonmethodist.org

Andrew Fararch, MD

CONTACT

713-441-4800 amfarach@houstonmethodist.org

Data from ClinicalTrials.gov

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