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

G

Grupo de Investigación Clínica en Oncología Radioterapia

Status

Completed

Conditions

Oligometastatic Prostate Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy for Oligometastases

Study type

Interventional

Funder types

Other

Identifiers

NCT02192788
SBRT-SG 05

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

SBRT
Experimental group
Description:
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
Treatment:
Radiation: Stereotactic Body Radiation Therapy for Oligometastases

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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