We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192788
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Antonio J Conde Moreno, Grupo de Investigación Clínica en Oncología Radioterapia

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 17, 2014
Last Update Posted Date November 19, 2021
Study Start Date  ICMJE August 2014
Actual Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
Number of patients without disease progression of prostate cancer treated by SBRT [ Time Frame: 5 years ]
Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
  • Overall Survival measured with Kaplan-Meier method [ Time Frame: patients will be followed up an average of 5 years ]
    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. [ Time Frame: 3 months after the SBRT treatment ]
    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 [ Time Frame: the patients will be followed up an expected average of 5 years ]
    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 [ Time Frame: baseline and 3rd month after the SBRT treatment. ]
    The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
  • Overall Survival measured with Kaplan-Meier method [ Time Frame: patients will be followed up an average of 5 years ]
    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. [ Time Frame: 3 months after the SBRT treatment ]
    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 [ Time Frame: the patients will be followed up an expected average of 5 years ]
    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 [ Time Frame: baseline and 3rd month after the SBRT treatment. ]
    The Functional Assessment Of Cancer Theraphy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Official Title  ICMJE Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oligometastatic Prostate Cancer
Intervention  ICMJE Radiation: Stereotactic Body Radiation Therapy for Oligometastases
Study Arms  ICMJE Experimental: SBRT
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
Intervention: Radiation: Stereotactic Body Radiation Therapy for Oligometastases
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2021
Actual Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02192788
Other Study ID Numbers  ICMJE SBRT-SG 05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Antonio J Conde Moreno, Grupo de Investigación Clínica en Oncología Radioterapia
Original Responsible Party Antonio J Conde Moreno, Hospital Provincial de Castellon, MD
Current Study Sponsor  ICMJE Grupo de Investigación Clínica en Oncología Radioterapia
Original Study Sponsor  ICMJE Hospital Provincial de Castellon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio J Conde Moreno, MD Grupo de Investigación Clínica en Oncología Radioterapia
PRS Account Grupo de Investigación Clínica en Oncología Radioterapia
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP