Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

NCT ID: NCT04141709

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2025-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

local ablative radiotherapy

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.

Group Type: EXPERIMENTAL

local ablative radiotherapy

Intervention Type: RADIATION

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.

Observational group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

Photons

Eligibility Criteria

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
• visceral metastasis (e.g. lung, liver, brain)
• lack of compliance
• previous taxane-containing chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Tobias Hölscher

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Hölscher, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology, Technische Universität Dresden

Locations

Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tobias Hölscher, Dr.

Role: CONTACT

str.studien@uniklinikum-dresden.de

+493514582238

Facility Contacts

Tobias Hölscher, Dr.

Role: primary

str.studien@uniklinikum-dresden.de

+493514582238

Other Identifiers

STR - Oli-CR-P - 2018

Identifier Type: -

Identifier Source: org_study_id