NL-OMON52631招募中3 期
Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy - ADOPT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
- •2. 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
- •2018. BCR after surgery: PSA >= 0.1ng/ml. BCR after radiotherapy: PSA nadir +2
- •ng/ml or 3 consequent rises in PSA level (after exclusion of possible bounce
- •3. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total,
- •without evidence of visceral metastases.
- •a. Nodal relapse (N1) 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 (M1a) 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.
- •d. Combination of a, b, c with a maximum of 4 metastases.
- •4. Age >= 18 years.
- •5. PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
- •6. PSA < 10 ng/ml.
- •7. In case of chronic use of finasteride the PSA value should be < 5 ng/ml.
- •8. WHO performance state 0-2.
- •9. Signed informed consent prior to registration/randomization.
排除标准
- •1. Visceral metastases.
- •2. PSA >= 10 ng/ml.
- •3. PSA-doubling time <= 3 months.
- •4. ADT or chemotherapy for recurrent PCa.
- •5. Testosterone < 1.7 nmol/l.
- •6. Painful metastases needed pain medication (> level 1 pain medication) .
- •7. Invasive active cancers other than superficial non-melanoma skin cancers.
- •8. Inability or unwillngness to understand the information on trial-related
- •topics, to give informed consent or to fill out QoL questionnaires.
研究者
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