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

Официальное название

High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Incidence of Adverse Events [Срок оценки: up to two years post RALP]
• Treatment Completion [Срок оценки: up to two years post RALP]

Вторичные конечные точки (7)

• Change From Baseline in International Prostate Symptom Score (IPSS) [Срок оценки: 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 [Срок оценки: Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)]
• Change in Prostate-Specific Antigen (PSA) [Срок оценки: Baseline and within 2 weeks prior to RALP (4-8 weeks after HDR brachytherapy)]
• Radiologic Tumor Response on Multiparametric MRI (mpMRI) [Срок оценки: Baseline and within 2 weeks prior to RALP]
• Pathologic Response in Prostatectomy Specimen [Срок оценки: At RALP (4-8 weeks after HDR brachytherapy)]
• Biochemical recurrence [Срок оценки: up to 24 months post RALP]
• Regional and distant metastasis [Срок оценки: Up to 24 months after RALP]

Критерии участия

Критерии включения

• 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\' 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.

Критерии исключения

• 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.
• Baseline IPSS \>15 with medical optimization.
• History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
• Unwilling or unable to comply with the study protocol.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Houston Methodist — Houston

Идентификаторы

NCT: NCT07182279 · Pro00038251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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