PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer

Официальное название

A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial

Обзор

The purpose of this prostate cancer research study is to learn about: 1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy; 2. Preserving quality of life after radiation therapy; 3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.

Вмешательства

• Лучевая терапия Para Aortic Radiation Therapy: Photon Therapy
  Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 50 grays (Gys) delivered in 25 fractions to the Clinical Tumor Volume (CTV).
• Лучевая терапия Para Aortic Radiation Therapy: Proton Therapy
  Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 60 to 65 Gys delivered in 25 fractions to the Gross Tumor Volume (GTVn).
• Препарат Androgen Deprivation Therapy
  Androgen deprivation therapy will be administered as per standard of care.
• Препарат Androgen Receptor Signaling Inhibitor
  Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.

Первичные конечные точки

• Progression-free Survival (PFS) [Срок оценки: Up to 2 years]

Вторичные конечные точки (10)

• Biochemical Failure-Free Survival (FFS) [Срок оценки: Up to 2 years]
• Metastasis-Free Survival [Срок оценки: Up to 2 years]
• Overall Survival (OS) [Срок оценки: Up to 2 years]
• Median Cause Specific Survival [Срок оценки: Up to 2 years]
• Proportion of Participants Undergoing Escalation of Therapy [Срок оценки: Up to 2 years]
• Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity [Срок оценки: Up to 2 years]
• Change in Quality of Life Scores: EPIC 26 Short Form [Срок оценки: Up to 2 years]
• Change in Quality of Life Scores: HADS [Срок оценки: Up to 2 years]
• Change in Quality of Life Scores: IPSS [Срок оценки: Up to 2 years]
• Complete Early Response Rate [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Histologically proven prostate adenocarcinoma
• Male, ≥ 18 years old
• Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes

• a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) > liver uptake and CT scan correlate)
• b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
• c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes
• d. Non-bulky nodal disease (ie, tumor <5 cm)
• Prior pelvic radiation with disease response

• a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or
• b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes
• Hormone-sensitive prostate cancer
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s)
• Willingness to fill out quality of life and psychosocial forms
• Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)

Критерии исключения

• No pathological diagnosis of prostate adenocarcinoma
• Patient has more than 5 sites of metastatic disease
• Patient has history of bone and/or visceral metastasis
• No evidence of disease in the para-aortic or pelvic lymph nodes
• No staging with PSMA PET/CT scan
• History of prior radiation therapy outside the pelvis for prostate cancer
• Bulky nodal disease >5 cm in tumor size
• Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
• Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
• Implanted hardware which limits treatment planning or delivery (determined by treating physician)
• Castration-resistant prostate cancer (history of rising PSA with serum testosterone level <50 ng/dL)
• Patients with ECOG performance status > 2
• History of inflammatory bowel disease
• History of malignancy other than prostate cancer except for non-melanoma skin cancer
• Patients unable to consent or are prisoners
• Unwilling to fill out quality of life and psychosocial forms
• Participants with impaired decision-making capacity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT06392295 · 20231278

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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