local ablative radiotherapy: Within the scope of the study, irradiation with two irradiation schemes is possible (the scheme applied is recorded in the CRF):
* Scheme A 3\*10 Gy (once a day, 2-3 days a week)
* Scheme B 25\*2 Gy (once a day, 5 days a week) The decision which irradiation scheme (3\*10 Gy or 25\*2 Gy) to use is made by the treating physician based on the anatomical position, the size of the metastases and the expected normal tissue load. Hypofractionated irradiation in three fractions is only possible if the limit values for the risk organs are adhered to. Radiotherapy should be performed with photons.
Study summary
The purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. The effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. Treatment can be stereotactically hypofractionated or conventionally fractionated.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Indication:
Oligometastases (1-5) in castration-resistant prostate carcinoma
Inclusion Criteria:
* Patient with good general condition (WHO 0-1)
* Histologically confirmed prostate carcinoma
* After definitive local therapy, e.g. radical prostatectomy or definitive radiotherapy (also after neo-adjuvant hormone therapy, after postoperative radiotherapy).
* PSA progression under ongoing androgen deprivation (defined as three consecutive increasing PSA values at intervals of \> 4 weeks and testosterone in the castration area \<50ng/dl or \<1.73nmol/)
* Minimum duration of androgen deprivation 6 months before inclusion in study
* Present complete staging (max. 6 weeks old), preferably by means of PET hybrid imaging with prostate-specific PET tracer
* Imaging detection of individual active or progressive metastases (max. 5, depending on location) that are accessible to local ablative radiotherapy (histological confirmation of the metastases is not required)
* No parallel participation to further clinical therapy trials up to 4 weeks before and after radiation therapy
* Individual case discussion in an interdisciplinary tumor board
* Patient's ability to consent and written consent
Exclusion Criteria:
* Severe concomitant disease that limits further life expectancy to \< 5 years according to the physician's assessment.
* PSA \> 20ng/ml, testosterone \>50 dl or \>1,73nmol/l
* visceral metastasis (e.g. lung, liver, brain)
* lack of compliance
* previous taxane-containing chemotherapy
Primary outcome measure(s)
Time to PSA progression — 12 month after randomization Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)
Trial sites (4)
Facility
City
Region
Status
Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden
Saxony
University Medical Center Freiburg, Department of Radiation Oncology
Freiburg im Breisgau
Germany
University Hospital Heidelberg, Department of Radiation Oncology
Heidelberg
Germany
University Clinic Tübingen, Clinic for Radiation Oncology
Tübingen
Germany
More Technische Universität Dresden trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.