Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer (OLI-CR-P)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oligometastatic Disease; Prostatic Cancer, Castration-Resistant
• Intervention / Treatment: Radiation: local ablative radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Indication:

Oligometastases (1-5) in castration-resistant prostate carcinoma

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Other Names: Photons
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to PSA progression	Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)	12 month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of PSA doubling time	PSA doubling time measured with the last three consecutive PSA values. Change of PSA doubling time compared to value before treatment	12 month after randomization
Number of patients without detection of new lesions	Number of patients without detection of new lesions at 12 months	12 month after randomization
Toxicity (CTCAE 5.0)	description of toxicity (CTCAE 5.0) ant 3 and 12 months.	3 and 12 month after therapy
Number of patients who have PSA response	Number of patients who have a PSA reduction of >50% at 12 months.	12 month after randomization
Time to tumor-specific systemic therapy after intervention	Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)	12 month after randomization
Number of patients with a limited number of metastases at PSA progression	Number of patients with a limited number of metastases at PSA progression, compared to patients with multiple metastases. (Arm B only)	12 month after randomization

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): February 28, 2024
• Study Completion (ANTICIPATED): February 28, 2025

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prostate Cancer; Radiation therapy; Oligometastatic Disease; Prostatic Cancer, Castration-Resistant
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant
• Other Study ID Numbers: STR - Oli-CR-P - 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No