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

Primary Purpose

Oligometastatic Disease, Prostatic Cancer, Castration-Resistant

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
local ablative radiotherapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligometastatic Disease focused on measuring Oligometastatic Disease, Prostate Cancer, Radiation therapy, Prostatic Cancer, Castration-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • lack of compliance
  • previous taxane-containing chemotherapy

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

local ablative radiotherapy

Observational group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of patients without detection of new lesions
Number of patients without detection of new lesions at 12 months
Toxicity (CTCAE 5.0)
description of toxicity (CTCAE 5.0) ant 3 and 12 months.
Number of patients who have PSA response
Number of patients who have a PSA reduction of >50% at 12 months.
Time to tumor-specific systemic therapy after intervention
Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)
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)

Full Information

First Posted
October 24, 2019
Last Updated
February 6, 2023
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT04141709
Brief Title
Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer
Acronym
OLI-CR-P
Official Title
Effektivität Und Toxizität Einer Perkutanen Hochdosierten Strahlentherapie Bei Patienten Mit Oligometastasen Eines Kastrationsresistenten Prostatakarzinoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligometastatic Disease, Prostatic Cancer, Castration-Resistant
Keywords
Oligometastatic Disease, Prostate Cancer, Radiation therapy, Prostatic Cancer, Castration-Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 randomized allocation to intervention (local ablative radiotherapy) or standard of care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local ablative radiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Observational group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
local ablative radiotherapy
Other Intervention Name(s)
Photons
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to PSA progression
Description
Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)
Time Frame
12 month after randomization
Secondary Outcome Measure Information:
Title
Change of PSA doubling time
Description
PSA doubling time measured with the last three consecutive PSA values. Change of PSA doubling time compared to value before treatment
Time Frame
12 month after randomization
Title
Number of patients without detection of new lesions
Description
Number of patients without detection of new lesions at 12 months
Time Frame
12 month after randomization
Title
Toxicity (CTCAE 5.0)
Description
description of toxicity (CTCAE 5.0) ant 3 and 12 months.
Time Frame
3 and 12 month after therapy
Title
Number of patients who have PSA response
Description
Number of patients who have a PSA reduction of >50% at 12 months.
Time Frame
12 month after randomization
Title
Time to tumor-specific systemic therapy after intervention
Description
Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)
Time Frame
12 month after randomization
Title
Number of patients with a limited number of metastases at PSA progression
Description
Number of patients with a limited number of metastases at PSA progression, compared to patients with multiple metastases. (Arm B only)
Time Frame
12 month after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Hölscher, Dr.
Phone
+493514582238
Email
str.studien@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Hölscher, Dr.
Organizational Affiliation
Radiation Oncology, Technische Universität Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Hölscher, Dr.
Phone
+493514582238
Email
str.studien@uniklinikum-dresden.de

12. IPD Sharing Statement

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Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

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