Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- The main study parameters are the fractions of patients that have disease progression (as a surrogate for progression free survival defined in paragraph 2: objectives) within 6-month follow up in the two arms
研究概览
简要总结
The primary aim is to study the effect of 177Lu-PSMA RLT in patients with oligo-metastatic, hormone sensitive metastatic PCa, by comparing the fraction of patients that have disease progression (as a surrogate for progression free survival) and meet EOT 1 criteria within 6 months in a group of patients that are treated with 177Lu-PSMA RLT and a group that follows the current standard of care (deferred androgen deprivation therapy).
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
- •Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure
- •Laboratory values: • White blood cells > 3.0 x 109/l • Platelet count > 75 x 109/l • Hemoglobin > 6.2 mmol/l • ASAT, ALAT < 3 x ULN • MDRD-GFR ≥ 50 ml/min
- •Signed informed consent
- •Biochemical recurrence (PSA > 1.0 μg/l)
- •PSA-doubling time < 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 μg/l
- •18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 metastases
- •Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions or if the patient refuse these treatments)
- •No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); testosterone > 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 6 months
- •A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax > 15 (partial volume corrected)
- •Patients must have a life expectancy >6 months
排除标准
- •A known subtype other than prostate adenocarcinoma
- •Previous PSMA based radioligand treatment
- •Visceral or brain metastases
- •Any medical condition present that in the opinion of the investigator will affect patients’ clinical status when participating in this trial
- •Prior hip replacement surgery potentially influencing performance of PSMA PET/CT
- •Sjogren's syndrome
- •A second active malignancy other than prostate cancer
- •Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
结局指标
主要结局
The main study parameters are the fractions of patients that have disease progression (as a surrogate for progression free survival defined in paragraph 2: objectives) within 6-month follow up in the two arms
The main study parameters are the fractions of patients that have disease progression (as a surrogate for progression free survival defined in paragraph 2: objectives) within 6-month follow up in the two arms
A second main study parameter is the time to disease progression and meeting EOT 1 criteria in both groups
A second main study parameter is the time to disease progression and meeting EOT 1 criteria in both groups
次要结局
- Secondary endpoints will be the ADT free survival, PSA response, toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), radiological state of the disease expressed in the difference in amount and size of suspicious nodes 18F-PSMA PET/(diagnostic) CT and (whole body) MRI between pre- and post-therapy and quality of life assessments, in both arms
研究者
Nuclear Medicine RLT research office
Scientific
Stichting Radboud University Medical Center