Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

Официальное название

Phase II Randomized Trial of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).

Обзор

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

Подробное описание

A multi-centre, open-label, phase II randomized clinical trial evaluating the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® compared to Recurrence Directed Therapy (RDT) alone in patients with previously localized prostate adenocarcinoma treated with definitive radiotherapy or with salvage radiotherapy after radical prostatectomy who experience biochemical recurrence and present with oligo-metastases (i.e., \< 5 sites of metastases) on conventional imaging. Eligible and consenting patents will be randomized in a 1:1 fashion to either RDT alone (standard arm) or RDT +ADT (ELIGARD®) x12 months (experimental arm). During treatment study participants will be assessed for disease progression, development of castrate resistant prostate cancer (CRPC), acute and late genitourinary (GU) and gastrointestinal (GI) radiotherapy toxicity, the occurrence of adverse events, initiation of tertiary therapy, overall survival and quality of life through the completion of participant questionnaires. Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months from the date of randomization. The planned sample size is 162 study participants.

Вмешательства

• Лучевая терапия Recurrence-directed therapy (RDT)
  RDT options include radiotherapy or surgical resection.
• Препарат ELIGARD 22.5mg
  ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.

Первичные конечные точки

• Composite progression free survival [Срок оценки: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.]

Вторичные конечные точки (8)

• Disease progression [Срок оценки: Time from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.]
• Time to initiation of tertiary therapy; [Срок оценки: Time of initial therapy to 36 month follow-up.]
• Proportion of patients that develop castrate-resistant prostate cancer (CRPC) [Срок оценки: During the 36 month follow-up.]
• Overall survival. [Срок оценки: During the 36 month follow-up.]
• Rate of early and late Grade 3 or higher GU and GI toxicity. [Срок оценки: At 3, 6, 15 and 36 months.]
• Quality of life assessed by EORTC QLQ C30 [Срок оценки: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).]
• Quality of life assessed by EORTC QLQ PR25 questionnaire [Срок оценки: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).]
• Quality of life assessed by EORTC QLQ PRT20 questionnaire [Срок оценки: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).]

Критерии участия

Критерии включения

• Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.
• Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.

Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI and PSMA-PET, will be accepted for study enrollment.

• All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.
• Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:

• After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;
• After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.

Критерии исключения

• Age < 18.
• ECOG Performance Status ≥3.
• PSA ≥ 20 ng/ml.
• Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.
• Prior treatment with chemotherapy for prostate cancer or bilateral orchiectomy. Note: prior chemotherapy for a different type of cancer is allowed if the patient has been continuously disease-free for > 3 years.
• Intracranial or intrathecal metastasis.
• Spinal cord compression, or spinal intramedullary metastasis.
• Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years.
• Bilateral hip prosthesis, treated earlier with definitive prostate radiotherapy, who have evidence of local disease recurrence within the prostate and no option for salvage treatment with brachytherapy or surgery.
• Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• Juravinski Cancer Centre — Hamilton
• The Ottawa Hospital Regional Cancer Centre — Ottawa
• Jewish General Hospital — Montreal

Идентификаторы

NCT: NCT06654336 · OCOG-2024-RATΙONAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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