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Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer

Primary Purpose

Oligometastatic Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy for Oligometastases
Sponsored by
Grupo de Investigación Clínica en Oncología Radioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligometastatic Prostate Cancer focused on measuring SBRT, Oligometastases, Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease.
  • Aged ≥ 18 years
  • Time to biochemical recurrence more than 1 year
  • PSA doubling time> 3 months
  • Less than 5 bone metastases location (including spinal) or lymph node.
  • Without other metastases or recurrences by Choline PET or / and NMR Diffusion Length.
  • Signed and dated written informed consent form.

Exclusion Criteria:

  • Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
  • Patients unwilling or unable to comply with protocol requirements and scheduled visits.

Sites / Locations

  • GICOR
  • Hospital Puerta de Hierro
  • Hospital Rey Juan Carlos
  • Santa Lucia
  • Instituto catalan de Oncología
  • Hospital de Cruces
  • C.H.P. Castellón
  • Hospital Dr. Negrin
  • Clínica QUIRON
  • Hospital central de la defensa Gomez Ulla
  • Hospital de Sanchinarro
  • Hospital Ramón y Cajal
  • Hospital Ruber Internacional
  • Hospital Universitario de la Princesa
  • Hospital Virgen de la Arrixaca
  • Hospital de Navarra
  • Hospital Universitario Clínico de Salamanca
  • Hospital marques de Valdecilla
  • ERESA H. General de Valencia
  • Hospital Universitari i Politècnic La Fe
  • Hospital Do Mexoeiro
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

Stereotactic Body Radiation Therapy for Oligometastases (SBRT)

Outcomes

Primary Outcome Measures

Number of patients without disease progression of prostate cancer treated by SBRT
Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage

Secondary Outcome Measures

Overall Survival measured with Kaplan-Meier method
the time to death will be defined as the time between the date when the patient is treated with SBRT and the date of death, or the last follow-up visit.
Number of patients with an adverse events.
Analyze toxicities in every patient during the first 3 months after the treatment with SBRT. Every significant Adverse Event will be graded as CTC-AE v.4.03. For Pain related adverse events, visual analogic scale (VAS) will be used.
Free disease progression survival measured with Kaplan-Meier method
the time to disease progression will be defined as the time between the date when the patient is treated with SBRT and the date of biochemical (PSA increased upper to 2 ng/mL) o radiological progression or the last follow-up visit.
Quality of life questionnaire FACT-P
The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.

Full Information

First Posted
July 3, 2014
Last Updated
November 18, 2021
Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT02192788
Brief Title
Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Official Title
Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to probe the effect of SBRT as a treatment oligometastases of prostate cancer, regardless of basal treatment received, and I know the response, biochemical control, the progression-free survival as well as their impact on quality of life. Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated by SBRT. Secondary Objectives: Analyzing biochemical progression rates, progression-free survival, chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of patients before and after treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligometastatic Prostate Cancer
Keywords
SBRT, Oligometastases, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Experimental
Arm Description
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy for Oligometastases
Primary Outcome Measure Information:
Title
Number of patients without disease progression of prostate cancer treated by SBRT
Description
Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival measured with Kaplan-Meier method
Description
the time to death will be defined as the time between the date when the patient is treated with SBRT and the date of death, or the last follow-up visit.
Time Frame
patients will be followed up an average of 5 years
Title
Number of patients with an adverse events.
Description
Analyze toxicities in every patient during the first 3 months after the treatment with SBRT. Every significant Adverse Event will be graded as CTC-AE v.4.03. For Pain related adverse events, visual analogic scale (VAS) will be used.
Time Frame
3 months after the SBRT treatment
Title
Free disease progression survival measured with Kaplan-Meier method
Description
the time to disease progression will be defined as the time between the date when the patient is treated with SBRT and the date of biochemical (PSA increased upper to 2 ng/mL) o radiological progression or the last follow-up visit.
Time Frame
the patients will be followed up an expected average of 5 years
Title
Quality of life questionnaire FACT-P
Description
The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.
Time Frame
baseline and 3rd month after the SBRT treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease. Aged ≥ 18 years Time to biochemical recurrence more than 1 year PSA doubling time> 3 months Less than 5 bone metastases location (including spinal) or lymph node. Without other metastases or recurrences by Choline PET or / and NMR Diffusion Length. Signed and dated written informed consent form. Exclusion Criteria: Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes. Patients unwilling or unable to comply with protocol requirements and scheduled visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio J Conde Moreno, MD
Organizational Affiliation
Grupo de Investigación Clínica en Oncología Radioterapia
Official's Role
Principal Investigator
Facility Information:
Facility Name
GICOR
City
Madrid
State/Province
Las Rozas
ZIP/Postal Code
28290
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
Country
Spain
Facility Name
Hospital Rey Juan Carlos
City
Móstoles
State/Province
Madrid
Country
Spain
Facility Name
Santa Lucia
City
Cartagena
State/Province
Murcia
Country
Spain
Facility Name
Instituto catalan de Oncología
City
Barcelona
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
Country
Spain
Facility Name
C.H.P. Castellón
City
Castellón De La Plana
Country
Spain
Facility Name
Hospital Dr. Negrin
City
Las Palmas De Gran Canaria
Country
Spain
Facility Name
Clínica QUIRON
City
Madrid
Country
Spain
Facility Name
Hospital central de la defensa Gomez Ulla
City
Madrid
Country
Spain
Facility Name
Hospital de Sanchinarro
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Ruber Internacional
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital de Navarra
City
Navarro
Country
Spain
Facility Name
Hospital Universitario Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital marques de Valdecilla
City
Santander
Country
Spain
Facility Name
ERESA H. General de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Do Mexoeiro
City
Vigo
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer

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