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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

Study Description
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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


Condition or disease Intervention/treatment Phase
Oligometastatic Prostate Cancer Radiation: Stereotactic Body Radiation Therapy for Oligometastases Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Study Start Date : August 2014
Actual Primary Completion Date : July 2021
Actual Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: SBRT
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
 Radiation: Stereotactic Body Radiation Therapy for Oligometastases


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192788


Locations
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Sponsors and Collaborators
Grupo de Investigación Clínica en Oncología Radioterapia
Investigators
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Principal Investigator: Antonio J Conde Moreno, MD Grupo de Investigación Clínica en Oncología Radioterapia
More Information
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Responsible Party: Antonio J Conde Moreno, MD, Grupo de Investigación Clínica en Oncología Radioterapia
ClinicalTrials.gov Identifier: NCT02192788    
Other Study ID Numbers: SBRT-SG 05
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Keywords provided by Antonio J Conde Moreno, Grupo de Investigación Clínica en Oncología Radioterapia:
SBRT
Oligometastases
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases