Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a monocentric, randomized, prospective Phase II intervention trial. Efficacy 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. Patients with PSA progression in the observation group are offered a new diagnosis. This should preferably correspond to the initial diagnosis.
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.
The decision as to which regimen the patient is to be treated according to is made by the treating physician, taking into account in particular the location of the volume to be irradiated in relation to the organs at risk and any previous irradiation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local ablative radiotherapy | Experimental | 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. |
|
| Observational group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local ablative radiotherapy | Radiation | Within the scope of the study, irradiation with two irradiation schemes is possible (the scheme applied is recorded in the CRF):
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA progression | Time to PSA progression (defined as PSA nadir after randomization +2ng/ml) | 12 month after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change of PSA doubling time | PSA doubling time measured with the last three consecutive PSA values. Change of PSA doubling time compared to value before treatment | 12 month after randomization |
| Number of patients without detection of new lesions |
Not provided
Indication:
Oligometastases (1-5) in castration-resistant prostate carcinoma
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Hölscher, Dr. | Contact | +493514582238 | str.studien@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Tobias Hölscher, Dr. | Radiation Oncology, Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42389925 | Derived | Holscher T, Lohaus F, Koi L, Kotzerke J, Hoberuck S, Thomas C, Borkowetz A, Lock S, Krause M, Troost EGC. Ablative radiotherapy in castration-resistant prostate cancer. BJU Int. 2026 Jul 2. doi: 10.1111/bju.70368. Online ahead of print. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017785 | Photons |
| ID | Term |
|---|---|
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
Not provided
Not provided
2:1 randomized allocation to intervention (local ablative radiotherapy) or standard of care
Not provided
Not provided
Not provided
Not provided
|
|
Number of patients without detection of new lesions at 12 months
| 12 month after randomization |
| Toxicity (CTCAE 5.0) | description of toxicity (CTCAE 5.0) ant 3 and 12 months. | 3 and 12 month after therapy |
| Number of patients who have PSA response | Number of patients who have a PSA reduction of >50% at 12 months. | 12 month after randomization |
| Time to tumor-specific systemic therapy after intervention | Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy) | 12 month after randomization |
| Number of patients with a limited number of metastases at PSA progression | Number of patients with a limited number of metastases at PSA progression, compared to patients with multiple metastases. (Arm B only) | 12 month after randomization |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D055590 |
| Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |