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START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC

NCT05209243 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2023-05-19

No results posted yet for this study

Summary

Phase III study of stereotactic body radiation therapy (SBRT) plus standard of care in castration sensitive oligometastatic prostate cancer patients, defined as androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients and second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) vs androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients plus second generation hormonal treatments, for the treatment of oligometastatic prostate cancer.

Conditions

Interventions

RADIATION

SBRT

SBRT (all metastatic lesions)

RADIATION

STANDARD OF CARE

ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

Sponsors & Collaborators

  • Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

    lead OTHER

Principal Investigators

  • Antonio J Conde Moreno, MD PhD · Grupo de Investigación Clínica en Oncología Radioterápica

  • Fernando López Campos, MD PhD · Grupo de Investigación Clínica en Oncología Radioterápica

  • Alfonso Gómez-Iturriaga, MD PhD · Grupo de Investigación Clínica en Oncología Radioterápica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2025-01-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209243 on ClinicalTrials.gov