2024-513450-30-00招募中3 期
EORTC protocol 1414-ROG-GUCG: Phase IIIb randomized trial comparing irradiation plus long-term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG. Pegasus
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi7 个研究点 分布在 3 个国家目标入组 476 人开始时间: 2024年8月7日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
- 试验地点
- 7
- 主要终点
- progression-free survival
研究概览
简要总结
To assess if GnRH antagonists improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy in patients with high-risk localized or locally-advanced cancer who receive this treatment after initial radical prostatectomy or as primary therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients may enter the trial once in either of two clinical settings where a combination therapy involving irradiation combined with androgen deprivation therapy is envisaged: a) patients who are scheduled for primary treatment by irradiation combined with minimum 18 months of androgen deprivation therapy or b) patients who were operated within the EORTC SPECTA 1553 study and who are scheduled to receive adjuvant or early salvage irradiation.
- •For all patients: Magnesium and potassium within normal limits at the institution
- •For all patients: WHO Performance status 0-1
- •For all patients: Age ≥ 18 and ≤ 80 years
- •For all patients: Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- •For all patients: Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •For patients planned for primary radiotherapy: Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed on a systematic ultrasound guided biopsy of the prostate containing at least 8 cores. An MRI-fusion biopsy is allowed if taken because a previous biopsy was negative. A TURP specimen pathology is allowed. Two of the following 4 risk factors for relapse: PSA ≥20 ng/ml; Gleason sum ≥8; cN1 (regional LN with a short axis length >10mm by CT scan or MRI) or pathologically confirmed lymph nodes (pN1); cT3-T4 (by MRI or core biopsy) (ie. If PSA≥20 ng/ml then only one of the other 3 risk factors is needed).
- •For patients previously enrolled in EORTC SPECTA 1553, treated by radical prostatectomy: Radical prostatectomy in EORTC SPECTA 1553performed within 1 year
- •For patients previously enrolled in EORTC SPECTA 1553, treated by radical prostatectomy: Scheduled to receive irradiation combined with 6 months of androgen deprivation therapy in the following cases: (1) In the adjuvant setting with PSA ≥ 0.1 ng/mL at 12 weeks postsurgery and/or ≥ 2 pathologically confirmed positive nodes after radical prostatectomy; (2) In the adjuvant setting with PSA ≥ 0.1 ng/mL at 12 weeks postsurgery and/or ≥ 2 pathologically confirmed positive nodes after radical prostatectomy.
- •For all patients: Either of (1) M0 according to standard imaging methods (i.e. bone scan and conventional CT/MR image) or M0 according to modern imaging methods (i.e. whole-body MRI, PET/CT); (2) M0 according to bone scan and conventional CT/MR image and M1a and M1b only with ≤ 3 lesions detected by modern imaging methods are also allowed, called "Oligometastatic disease". Patients with oligometastatic disease will undergo metastasis targeted therapy.
- •For all patients: Testosterone ≥ 200 ng/dL
- •For all patients: Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 109/L; hemoglobin ≥ 10.0 g/dl; platelets ≥ 100 109/L)
- •For all patients: Adequate hepatic function: (1) Bilirubin: total bilirubin ≤ 1.5 x upper limit of normal (ULN). (2) AST and/or ALT ≤ 2.5 x ULN.
- •For all patients: Adequate renal function: calculated creatinine clearance ≥ 50 mL/min
排除标准
- •M1c, confirmed by any imaging method or biopsy
- •Any contraindication to external beam radiotherapy
- •Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.
- •Previous use of androgen deprivation therapy, antiandrogens if not interrupted for more than 6 months prior to entering the study
- •History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angiodema.
- •Hypersensitivity towards any of the active substances, the excipients used and synthetic GnRH or GnRH derivatives
- •No severe hepatic impairment (Child Pugh C)
- •Uncontrolled diabetes mellitus
- •Coronary revascularization (PCI or multivessel CABG), carotid artery or iliofemoral artery revascularizaton (percutaneous or surgical procedure) within the last 30 days prior to entering the trial
- •Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (eg, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >450 ms
- •Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug(s). Prior history of bladder cancer (except appropriately treated Tis or T1a) excludes the patient
结局指标
主要结局
progression-free survival
progression-free survival
次要结局
- 1. Clinical progression-free survival
- 2. Time to next systemic anticancer therapy
- 3. Time to next systemic anticancer therapy other than ADT
- 4. Proportion of patients switching from GnRH antagonists to GnRH agonists and total effective duration of treatment with the originally allocated drug.
- 5. Overall survival
- 6. Prostate Cancer specific survival
- 7. PSA
- 8. The incidence of clinical cardiovascular events – CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events.
- 9. The incidence of urinary tract infection
- 10. Patient reported outcomes: (a) International Prostate Symptoms Score (I-PSS) (urinary symptoms); (b) Quality of Life (HRQoL) measured with EORTC QLQ-C30 and PR25 instruments with the overall health related quality of life scale as primary scale; (c) EQ-5L (to enable a future health economics analysis)
研究者
Stéphanie Kromar
Scientific
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
研究点 (7)
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