Clinical trial · Observational
Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma
Effectiveness and Toxicity of a Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma
NCT02264379CI-TRIAL-00063785Oli-PcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastatic Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypo fractionated irradiation | Radiation | — | UNRESOLVED |
| normal fractionated irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- normal fractionated irradiation
- interventionNames
- Radiation: normal fractionated irradiation
- label
- hypo fractionated irradiation
- interventionNames
- Radiation: hypo fractionated irradiation
Primary outcomes (1)
- measure
- Late Toxicity at year 2 after ablatvie radiotherapy
- timeFrame
- 24 months after therapy
- description
- The toxicity will be scored (CTCAE 4.03) at each follow up visit, the status will be recorded by clinical examination and radiological imaging.
Secondary outcomes (5)
- measure
- Early toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.