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

This study is currently recruiting participants.
Verified August 2016 by Antonio J Conde Moreno, Hospital Provincial de Castellon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02192788
First Posted: July 17, 2014
Last Update Posted: August 4, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Hospital Provincial de Castellon
Information provided by (Responsible Party):
Antonio J Conde Moreno, Hospital Provincial de Castellon
  Purpose

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 Intervention Phase
Oligometastatic Prostate Cancer Radiation: Stereotactic Body Radiation Therapy for Oligometastases Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Antonio J Conde Moreno, Hospital Provincial de Castellon:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 68
Study Start Date: August 2014
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
Radiation: Stereotactic Body Radiation Therapy for Oligometastases

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Antonio J Conde Moreno, MD 0034 964354342

Locations
Spain
Hospital Provincial de Castellón Recruiting
Castellon, Castellón, Spain, 12002
Contact: Antonio J Conde Moreno, MD    0034 964354342      
Contact: Francisco Garcia-Pinon    0034 964354525    francisco.garpi@hospitalprovincial.es   
Principal Investigator: Antonio J Conde Moreno, MD         
Sub-Investigator: Carlos Ferrer Albiach, MD         
Sub-Investigator: Angel L Sanchez Iglesias, MD         
Sub-Investigator: Rodrigo Muelas Soria, MD         
Sub-Investigator: Maria Albert Antequera, MD         
Sponsors and Collaborators
Grupo de Investigación Clínica en Oncología Radioterapia
Hospital Provincial de Castellon
  More Information

Responsible Party: Antonio J Conde Moreno, MD, Hospital Provincial de Castellon
ClinicalTrials.gov Identifier: NCT02192788     History of Changes
Other Study ID Numbers: SBRT-SG 05
First Submitted: July 3, 2014
First Posted: July 17, 2014
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Antonio J Conde Moreno, Hospital Provincial de Castellon:
SBRT
Oligometastases
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases