Actively Recruiting

Phase Not Applicable
MALE
NCT05209243

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

Led by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Updated on 2023-05-19

266

Participants Needed

2

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of prostate cancer
  • Castration sensitive prostate cancer
  • Oligometastatic disease with  3 lesions on CT and Bone Scan or  5 lesions on Choline or PSMA PET/CT
  • Bone and/or lymph node metastases
  • Informed consent obtained
  • Adequate bone marrow, liver, and kidney function: Hemoglobin 10 g/dL, Leucocytes  2000/mm3, Neutrophils  1500/mm3, Platelets  100000/mm3; GOT, GPT, Total Bilirubin  1.5 x ULN; Creatinine  1.5 x ULN or Creatinine Clearance  50 ml/min
Not Eligible

You will not qualify if you...

  • No histological diagnosis of prostate cancer
  • Castration resistant prostate cancer
  • More than 3 lesions on CT and Bone Scan or more than 5 lesions on Choline or PSMA PET/CT
  • Presence of visceral metastases
  • Tumor stage T4 by AJCC 8th Edition
  • Prior treatment with docetaxel, second generation hormonal treatments, or bone antiresorptive therapy
  • Signs or symptoms requiring urgent surgery or radiotherapy for metastatic disease
  • Lesions exceeding organ tolerance for SBRT or not suitable for SBRT
  • History of uncontrolled other cancers except basal cell carcinoma
  • Cardiopathy, metabolic disorders, inflammatory bowel disease, or other conditions contraindicating hormonal or radiotherapy treatments
  • Lack of informed consent or inability to consent
  • Participation in other clinical trials currently or within past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Actively Recruiting

2

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Not Yet Recruiting

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Research Team

A

Antonio J Conde Moreno, MD PhD

CONTACT

F

Fernando López Campos, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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