Oligometastatic Prostate Cancer Clinical Trial
Official title:
Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
NCT number | NCT02192788 |
Other study ID # | SBRT-SG 05 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | July 2021 |
Verified date | November 2021 |
Source | Grupo de Investigación Clínica en Oncología Radioterapia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Grupo de Investigación Clínica en Oncología Radioterapia |
Spain,
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. |
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