NCT02264379

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 3 months * Then, every 3 months for 1 year, and then * 1 time a year after that, for as long as possible Additional follow up visits may be scheduled, if the responsible physician thinks they are needed. At these visits, the following tests and procedures will be performed: * Any updates to the medical history of the patient will be recorded and the patient will be asked about any side effects the patient may be having. * The patient's performance status will be recorded. * The patient's complete symptom questionnaires will be reviewed. * The patient will have a clinical examination * The patient will have follow-up imaging (such as an MRI) to check the status of the disease. This is an observational study. Radiation therapy is delivered using CE-certified and commercially available methods.

Conditions

• Oligometastatic Disease
• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	normal fractionated irradiation	25\*2 Gy (once a day, 5 days a week)
RADIATION	hypo fractionated irradiation	3\*10 Gy (once a day, 2-3 days a week)

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-10-01
• Completion: 2021-08-01
• First posted: 2014-10-15
• Last updated: 2023-02-08

Locations

2 sites across 1 country: Germany