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Completed

NCT Number: NCT02192788

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

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

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Key information

Conditions

Oligometastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

GICOR, Madrid, Las Rozas, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Body Radiation Therapy for Oligometastases

Radiation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2014
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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