2024-511252-41-00招募中3 期
ADOPT; Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- The primary endpoint is the 2-year metastases progression free survival
研究概览
简要总结
The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone
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
- •Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
- •Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines
- •BCR after surgery: PSA > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).
- •Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. b. Nodal relapse (Ml) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes. c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.
- •Age > 18 years.
- •PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
- •PSA < 10 ng/ml.
- •In case of chronic use of finasteride the PSA value should be < 5 ng/ml.
- •WHO performance state 0-
- •DSigned informed consent prior to registration/randomization.
排除标准
- •Visceral metastases.
- •PSA => 10 ng/ml.
- •PSA-doubling time < 3 months.
- •ADT or chemotherapy for recurrent PCa.
- •Testosterone < 1.7 nmol/l.
- •Painful metastases needed pain medication.
- •Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.
- •Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
结局指标
主要结局
The primary endpoint is the 2-year metastases progression free survival
The primary endpoint is the 2-year metastases progression free survival
次要结局
- 3 years PSA progression.
- Start of 2nd line treatment.
- Start 2nd MDRT treatment for new (progressive) oligometastases.
- Acute and late toxicity (late toxicity up to 3 years).
- Clinical progression-free survival.
- Quality of life.
- Progression pattern.
- Time to start of palliative ADT.
- Time to castration-resistance.
- Disease-specific and overall survival.
- Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for patients receiving MDRT.
- Predictive biomarkers.
研究者
S. Aluwini
Scientific
Universitair Medisch Centrum Groningen
研究点 (10)
Loading locations...
相似试验
招募中
3 期
Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapyprostaat kankerhormoneradiotherapyNL-OMON52631Academisch Medisch Centrum280
进行中（未招募）
1 期
Comparison of targeted radiotherapy with and without short-term hormonal treatment (6 months)CTIS2024-511252-41-00niversitair Medisch Centrum Groningen280
进行中（未招募）
4 期
The effect of intermittent versus continuous androgen deprivation therapy in Chinese patients with advanced prostate cancer: A prospective controlled Trial from ChinaCancer - Prostateprostate cancerACTRN12613000107729Changhai Hospital, Second Military Medical University100
进行中（未招募）
Unknown
Testing the addition of new treatments to standard treatment in prostate cancer that has spread to other areas of the bodyMetastatic hormone-sensitive prostate cancerCancerISRCTN66357938niversity College London4,914
进行中（未招募）
不适用
Trial investigating hormone injections, external beam radiotherapy and intravenous radionuclide injection in patients with advanced prostate cancer.Metastatic castration sensitive prostate cancerEUCTR2014-000273-39-GBBelfast Health and Social Care Trust