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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2021-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Oligometastatic Prostate Cancer

Keywords

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SBRT Oligometastases Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT

Stereotactic Body Radiation Therapy for Oligometastases (SBRT)

Group Type EXPERIMENTAL

Stereotactic Body Radiation Therapy for Oligometastases

Intervention Type RADIATION

Interventions

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Stereotactic Body Radiation Therapy for Oligometastases

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Antonio J Conde Moreno

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio J Conde Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Grupo de Investigación Clínica en Oncología Radioterapia

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Conde-Moreno AJ, Lopez-Campos F, Hervas A, Morillo V, Mendez A, Puertas MDM, Valero-Albarran J, Gomez Iturriaga A, Rico M, Vazquez ML, Samper Ots PM, Perez-Romasanta LA, Pastor J, Ibanez C, Ferrer F, Zapatero A, Garcia-Blanco AS, Rodriguez A, Ferrer C. A Phase II Trial of Stereotactic Body Radiation Therapy and Androgen Deprivation for Oligometastases in Prostate Cancer (SBRT-SG 05). Pract Radiat Oncol. 2024 Sep-Oct;14(5):e344-e352. doi: 10.1016/j.prro.2024.04.022. Epub 2024 Jun 29.

Reference Type DERIVED

PMID: 38944806 (View on PubMed)

Other Identifiers

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SBRT-SG 05

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

SBRT

Stereotactic Body Radiation Therapy for Oligometastases

Interventions

Stereotactic Body Radiation Therapy for Oligometastases

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Grupo de Investigación Clínica en Oncología Radioterapia

Responsible Party

Antonio J Conde Moreno

Principal Investigators

Antonio J Conde Moreno, MD

Locations

GICOR

Hospital Puerta de Hierro

Hospital Rey Juan Carlos

Santa Lucia

Instituto catalan de Oncología

Hospital de Cruces

C.H.P. Castellón

Hospital Dr. Negrin

Clínica QUIRON

Hospital central de la defensa Gomez Ulla

Hospital de Sanchinarro

Hospital Ramón y Cajal

Hospital Ruber Internacional

Hospital Universitario de la Princesa

Hospital Virgen de la Arrixaca

Hospital de Navarra

Hospital Universitario Clínico de Salamanca

Hospital marques de Valdecilla

ERESA H. General de Valencia

Hospital Universitari i Politècnic La Fe

Hospital Do Mexoeiro

Hospital Miguel Servet

Countries

References

Other Identifiers

SBRT-SG 05