2023-506032-33-00招募中3 期
PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)
Universitaetsklinikum Essen AöR1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2025年7月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS), defined as time from initiation of RT to - biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy [71] - appearance of metastases or loco-regional recurrence as defined below - death from any cause whichever occurs first
研究概览
简要总结
To assess difference in efficacy between curative-intent RT based on PSMA PET vs based on standard-of care imaging, in patients with primary prostate cancer (intermediate- or high-risk) for whom curative-intent RT is appropriate given the imaging results.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The participant must agree not to donate sperm for the purpose of reproduction until 24 hours following the dose of study intervention
- •18 years of age or older
- •Signed an informed consent form (ICF) indicating that the participant understands the purpose of, and the procedures required for the study and is willing to participate in the study: participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •Histopathology-confirmed adenocarcinoma of the prostate.
- •Intermediate- to high-risk disease (PSA>10ng/mL, cT-stage≥2b, Gleason score≥7 or Decipher Score ≥0.45)
- •Willingness to undergo radiotherapy.
- •Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (arm 2)
- •Eastern Cooperative Oncology Group Performance Status Grade 0 or
- •The participant must wear a condom when engaging in any sexual activity that allows the passage of ejaculate to another person while on study intervention, and for 24 hours following the dose of study intervention. Participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.
排除标准
- •Extra-pelvic metastases (M1 disease) on any imaging or biopsy done before randomization.
- •Previous treatment with ADT for prostate cancer
- •Prior treatment with a CYP17 inhibitor (e.g., oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any AR antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
- •Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
- •Any of the following within 6 months prior to the trial intervention: severe or unstable angina, myocardial infarction, pulmonary embolism, stroke, clinically significant ventricular arrhythmias or NYHA Class II to VI heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
- •Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization
- •Prior chemotherapy for prostate cancer
- •Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 of the SmPC of 68Ga-PSMA-11 or to any of the components of the labelled radiopharmaceutical
- •Active malignancies (i.e., Progressing or requiring treatment change in the last 24 months) other than disease being treated under study. Allowed exceptions [...]
- •Contraindications to radiotherapy (including active inflammatory bowel disease)
- •Concurrent or prior surgery or systemic therapy for prostate cancer
- •Any kind of radiopharmaceutical within a period corresponding to 8 half-lives of the respective radionuclide
- •Any other investigational medicinal product within 2 days or within 5 times the elimination half-life of the respective investigational product prior receiving study intervention
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant
- •Prior PSMA PET
- •Prior pelvic RT
结局指标
主要结局
Progression-free survival (PFS), defined as time from initiation of RT to - biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy [71] - appearance of metastases or loco-regional recurrence as defined below - death from any cause whichever occurs first
Progression-free survival (PFS), defined as time from initiation of RT to - biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy [71] - appearance of metastases or loco-regional recurrence as defined below - death from any cause whichever occurs first
次要结局
- Change in initial treatment intent
- Metastasis-free survival (MFS), defined as time from initiation of RT to occurrence of new metastases defined as - PET or radiographic bone or soft tissue distant metastases by blinded independent central review* - pathologic finding of distant metastases - death from any cause whichever occurs first
- Loco-regional control (pelvis) Occurrence of loco-regional progression defined as (whichever occurs first): - PET or radiographic pelvic non-bone PCa lesions by blinded independent central review* - Pathologic finding of pelvic non-bone PCa lesions
- Overall survival (OS), defined as time from initiation of RT to death from any cause.
- Post-salvage bPFS - In patients without salvage therapy: Time from initiation of RT until progression as defined above (primary endpoint) - In patients with salvage therapy: Time from initiation of RT until progression post-salvage therapy as defined above (primary endpoint) *Following the joint EAU ESUR ESTRO SIOG 2018 guideline, Section 6.3.4.4
- Safety endpoints: Adverse events of CTC grade ≥3 and serious adverse events (SAE) according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, v5.0, 2017).
研究者
Wolfgang Fendler
Scientific
Universitaetsklinikum Essen AöR
研究点 (1)
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