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
Not provided
Not provided
Not provided
Not provided
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.
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 physician. Up to 71 patients will be enrolled in the study.
If the patient is treated with standard radiotherapy, the patient will receive 25 fractions of 2 Gy to the metastases, the treatment duration will be 5 weeks.
If the patient is treated with image-guided hypofractionated radiotherapy, the patient will receive 3 fractions of 10 Gy to the metastases, the treatment duration will be 1 week.
Radiation Planning and Treatment:
During all radiation treatments, the images that are taken during the treatment will be closely analyzed after treatment is over. The patient will have 3 to 25 radiation treatments per metastasis depending on the discretion of the responsible physician.
The rest of the radiation treatment planning and treatment delivery appointments will be unchanged. The dose given to the tumor and number of treatments the patient will receive, will be determined by the discretion of the responsible physician, and is not affected by taking part in this study.
Follow-Up Visits:
After the radiation treatment schedule ends, the patient will return for follow-up visits at the following time points:
At these visits, the following tests and procedures will be performed:
This is an observational study. Radiation therapy is delivered using CE-certified and commercially available methods.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal fractionated irradiation |
| ||
| hypo fractionated irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal fractionated irradiation | Radiation | 25*2 Gy (once a day, 5 days a week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Toxicity at year 2 after ablatvie radiotherapy | The toxicity will be scored (CTCAE 4.03) at each follow up visit, the status will be recorded by clinical examination and radiological imaging. | 24 months after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Early toxicity | The toxicity will be scored (CTCAE 4.03) at 3 months follow up visit, the status will be recorded by clinical examination and radiological imaging. | until day 90 after start radiotherapy |
| Quality of life (QLQ-C30 and QLQ-PR25) during Follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with oligometastases (1-5) and state after local therapy of prostate cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tobias Hölscher, Dr. | Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology | Dresden | Saxony | 01307 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood before therapy, at the end of radiotherapy, three months after the end of radiotherapy and at progress before starting further treatment
| hypo fractionated irradiation | Radiation | 3*10 Gy (once a day, 2-3 days a week) |
|
QoL will be assessed with the QoL-Questionaires QLQ-C30 and QLQ-PR25 at baseline, 3, 12 and 24 months after treatment. |
| 24 months after end of therapy |
| Local control of irradiated tumor manifestations | The tumor response will be evaluated (RECIST) at follow up visit 3,12 and 24 months after end of treatment, the status will be recorded by clinical examination and radiological imaging. | 24 months after end of therapy |
| Therapy-free survival | Therapy-free survival will be assessed as time from start of radiation to start of systemic treatment or androgen deprivation. The status will be assessed at each follow-up visit. | 24 months after end of therapy |
| PSA relapse-free survival | PSA relapse-free survival will be assessed as time from start of radiation to PSA-rise more than 20% above baseline. PSA - value will be assessed by blood testing. | 24 months after end of therapy |
| Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology | Tübingen | 72016 | Germany |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |