PRostate Only radiotherapy versus radiotherapy to all Sites in Oligo-metastatic prostate cancer (PROS-O) - A phase II randomized open label study - PROS O

Intramural Tata memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•Metastatic prostate cancer (Oligo-metastases i.e. metastases)
•Patient must have 1-5 asymptomatic/ mildly symptomatic metastatic tumor(s) of the bone and soft tissue /liver/ lung/ lymph node developed that are amenable for SABR.
•Patient must not have had their primary tumor treated with radiation.
•Histologic confirmation of malignancy (primary or metastatic tumor).
•Prostate specific antigen (PSA) Ã¢â?°Â¥ 0.5 ng/mL
•Hormone sensitive and castration resistant prostate cancer
•PSMA PET not older than 2 months from randomization
•Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer.
•Patient must be Ã¢â?°Â¥ 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document.
•Patient must have an Eastern Cooperative Oncology Group performance status Ã¢â?°Â¤ 2.
•Patient must have normal organ and marrow function as defined as: Leukocytes >2,000/Ã?Â¼L, absolute neutrophil count >1,000/Ã?Â¼L, platelets >50,000/Ã?Â¼L

•No more than 3 years of ADT is allowed
•Spinal cord compression or impending spinal cord compression.
•Suspected pulmonary and/or liver metastases not amenable for SABR
•Receipt of any other investigational agents or participation in a concurrent treatment protocol
•Large TURP defects
•Moderate-severe urinary symptoms (e.g. high IPSS score, typically defined as IPSS > 20)
•Excessive artefact not allowing proper localization of prostate e.g. Hip replacement
•Serum creatinine and total bilirubin > 3 times the upper limit of normal
•Liver Transaminases > 5-times the upper limit of normal or intractable ascites
•Inability to lie flat during or tolerate PET/CT, PET/MRI or SABR.
•Refusal to sign informed consent

发起方

Intramural Tata memorial Centre