Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer (OLI-CR-P)
Oligometastatic Disease, Prostatic Cancer, Castration-Resistant
About this trial
This is an interventional treatment trial for Oligometastatic Disease focused on measuring Oligometastatic Disease, Prostate Cancer, Radiation therapy, Prostatic Cancer, Castration-Resistant
Eligibility Criteria
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
- lack of compliance
- previous taxane-containing chemotherapy
Sites / Locations
- Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität DresdenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
local ablative radiotherapy
Observational group
The therapy is performed for all patients in the intervention arm using high-dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy.
Effectiveness is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml). There is a 2:1 randomization between intervention and observation group.