Status:
COMPLETED
Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma
Lead Sponsor:
Technische Universität Dresden
Conditions:
Oligometastatic Disease
Prostate Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the outcomes of patients treated with an high dose radiation regimen using either stereotactic hypofractionated or normofractionated radiotherapy for oligometa...
Detailed Description
Study Groups: If the patient found to be eligible to take part in this study, the patient will be assigned to a study group based on the size of the lesion(s) and the discretion of the responsible ph...
Eligibility Criteria
Inclusion
- Patient with good general condition (WHO 0-1)
- No comorbidities which limit the further life expectancy of the patient to \<5 years (opinion of the physician)
- Histologically confirmed prostate cancer
- State after definitive local therapy, such as radical prostatectomy or definitive radiotherapy (even after neo-/-adjuvant hormone therapy, after postoperative radiotherapy)
- PSA relapse after primary therapy or radiological unique metastasis, present complete staging (up to 8 weeks old) by CT thorax/ abdomen/ pelvis and bone scan alternatively a hybrid imaging PET (positron emission tomography) (acetate PET, PET-PSMA, NAFL-PET) and CT / MRI is sufficient
- Imaging detection of individual metastases (up to 5, depending on the situation) that a Radiation therapy are available (histological confirmation of the MET is not required)
- No parallel participation to further clinical therapeutic trials to 4 weeks and after radiation
- Consent of the patient and written informed consent
Exclusion
- severe comorbidity which limit the further life expectancy of the patient to \<5 years (opinion of the physician)
- PSA in PSA relapse\> 10ng/ml
- Ongoing androgen deprivation at the time of study inclusion
- not been carried out local therapy
- no histological confirmation of prostate cancer
- lack of compliance
- absence of consent of the patient
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT02264379
Start Date
December 1 2014
End Date
August 1 2021
Last Update
February 8 2023
Active Locations (2)
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1
Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Dresden, Saxony, Germany, 01307
2
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
Tübingen, Germany, 72016