A phase II/III trial of primary radiotherapy for androgen sensitive prostate cancer patients with lymph nodes

Institute of Cancer Research0 个研究点目标入组 893 人开始时间: 2021年6月9日最近更新: 2024年6月18日

适应症

试验速览

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36238579/ (added 04/06/2024)

•1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old).
•2. Any T stage, N1, M0; any T stage, N1, M1a (limited to para-aortic region); or any T stage, N0, M1a (limited to para-aortic region) on PSMA PET-CT imaging done at time of diagnostic staging (stage IV disease).
•3. Age at least 18 years.
•4. Patient on LHRH analogue therapy.
•5. Adequate renal and bone marrow function.
•6. WHO Performance status of 0-2.
•7. Written informed consent.

•1. Prior radiotherapy to the prostate or pelvis; prior bilateral orchiectomy; radical prostatectomy.
•2. For those patients who have received docetaxel chemotherapy or are receiving androgen receptor targeted therapy, there should be no ongoing CTCAE grade 2 or greater GI toxicity relating to this systemic therapy.
•3. Medical conditions (non-prostate cancer related) expected to limit life expectancy to < 5 years.
•4. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.
•5. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, intractable urinary symptoms, previous colorectal surgery.
•6. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin or small renal masses under surveillance), or if previous malignancy is expected to significantly compromise 5 year survival.
•7. Any other contraindication to external beam radiotherapy to the para-aortic and/or pelvic region.

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