ADOPT; Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy - RT2019-13

niversitair Medisch Centrum Groningen0 个研究点目标入组 280 人开始时间: 2024年7月4日最近更新: 2024年8月21日

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•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 2018. 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 0-2., DSigned informed consent prior to registration/randomization.

•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.

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