Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

NCT04141709 | Unknown

• 1 other identifier: STR - Oli-CR-P - 2018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Oligometastatic Disease; Prostatic Cancer, Castration-Resistant

Keywords

Oligometastatic Disease; Prostate Cancer; Radiation therapy; Prostatic Cancer, Castration-Resistant

Outcome Measures

Primary Outcomes (1)

• Time to PSA progression

  Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)

  12 month after randomization

Secondary Outcomes (6)

• Change of PSA doubling time

  12 month after randomization

• Number of patients without detection of new lesions

  12 month after randomization

• Toxicity (CTCAE 5.0)

  3 and 12 month after therapy

• Number of patients who have PSA response

  12 month after randomization

• Time to tumor-specific systemic therapy after intervention

  12 month after randomization

Study Arms (2)

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.

Radiation: local ablative radiotherapy

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.

Interventions

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): * 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.

Also known as: Photons

local ablative radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms

Interventions

Photons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Tobias Hölscher, Dr.

  Radiation Oncology, Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Hölscher, Dr.

CONTACT

+493514582238; str.studien@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2:1 randomized allocation to intervention (local ablative radiotherapy) or standard of care

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: December 1, 2019
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

DE (1)