Phase II trial in men with rising PSA post-prostatectomy, harnessing PSMA-PET to identify local recurrence only and implanted Calypso real-time tracking beacons to measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.

Icon Cancer Foundation0 个研究点目标入组 110 人开始时间: 2015年11月3日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•Phase I (PSMA PET/CT)
•- Males age 18 years or older.
•- Patients who have undergone radical prostatectomy for histologically confirmed clinical stage T1- T3 invasive prostate adenocarcinoma.
•- Post-operative PSA 0.1-2.5ng/ml.
•- No contraindications to undergoing 68Ga-PSMA-ligand PET/CT (including severe claustrophobia).
•- ECOG Status 0-2
•- Able to undergo intensity modulated radiotherapy.
•- Patients or their legal representatives must have the ability to read, understand and provide written informed consent.
•- Able to participate in the stipulated follow-up (either telephone follow-up or on-site visits acceptable, but one follow-up annually should be in person).
•- Participants capable of child-bearing are using adequate contraception.
•Phase II (radiotherapy)
•- No evidence of metastatic disease on PSMA-PET
•- localized recurrence on PSMA-PET
•Inclusion criteria for Calypso beacons
•- Body habitus enabling Calypso (Registered Trademark) localisation and tracking (as per Calypso (Registered Trademark) Determining a Patient’s Localisation Designation & Orientation before implantation).
•- Able to undergo Calypso (Registered Trademark) beacon insertion.

•- Prostate cancer with significant sarcomatoid, ductal, spindle cell or neuroendocrine small cell components.
•- Evidence of secondary disease outside the prostate bed.
•- Previous radiotherapy treatment to the pelvis.
•- Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer.
•- Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer.
•- Inflammatory bowel disease (active) such as Crohn’s disease and ulcerative colitis.
•- Haemorrhagic cystitis.
•- Known hypersensitivity to 68Ga, PSMA or any of the excipients of 68Ga-PSMA.
•- Insufficient renal function (eGFR < 30 mL/min/1.73 m2).
•- Androgen Deprivation Therapy within 6 months prior to enrolment.
•- Unable to lie flat and/or still during PET-CT.
•- Patients unable or unwilling to comply with study requirements.
•- Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
•Exclusion criteria for Calypso beacon insertion:
•- Any urogenital anatomic abnormality that would interfere with the ability to access the Calypso (Registered Trademark) beacon insertion site.
•- Pacemaker or implanted defibrillator.
•- Presence of hip prosthesis.

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