NCT04141709

Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

Effektivität Und Toxizität Einer Perkutanen Hochdosierten Strahlentherapie Bei Patienten Mit Oligometastasen Eines Kastrationsresistenten Prostatakarzinoms

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Oligometastatic Disease
• Prostatic Cancer, Castration-Resistant

Interventions

Type	Name	Description
RADIATION	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2024-02-28
• Completion: 2025-02-28
• First posted: 2019-10-28
• Last updated: 2023-02-08

Locations

1 site across 1 country: Germany