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

Oligometastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192788
• Other study ID #: SBRT-SG 05
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 2021

Study information

• Verified date: November 2021
• Source: Grupo de Investigación Clínica en Oncología Radioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oligometastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy for Oligometastases

Locations

Country	Name	City	State
Spain	Instituto catalan de Oncología	Barcelona
Spain	Hospital de Cruces	Bilbao
Spain	Santa Lucia	Cartagena	Murcia
Spain	C.H.P. Castellón	Castellón De La Plana
Spain	Hospital Dr. Negrin	Las Palmas De Gran Canaria
Spain	Clínica QUIRON	Madrid
Spain	GICOR	Madrid	Las Rozas
Spain	Hospital central de la defensa Gomez Ulla	Madrid
Spain	Hospital de Sanchinarro	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Rey Juan Carlos	Móstoles	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital de Navarra	Navarro
Spain	Hospital Universitario Clínico de Salamanca	Salamanca
Spain	Hospital marques de Valdecilla	Santander
Spain	ERESA H. General de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital Do Mexoeiro	Vigo
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Investigación Clínica en Oncología Radioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients without disease progression of prostate cancer treated by SBRT	Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage	5 years
Secondary	Overall Survival measured with Kaplan-Meier method	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.	patients will be followed up an average of 5 years
Secondary	Number of patients with an adverse events.	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 months after the SBRT treatment
Secondary	Free disease progression survival measured with Kaplan-Meier method	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.	the patients will be followed up an expected average of 5 years
Secondary	Quality of life questionnaire FACT-P	The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.	baseline and 3rd month after the SBRT treatment.