Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06585007

Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-09-05

246

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

CONDITIONS

Official Title

Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent has been obtained before any screening.
  • Diagnosed with acinar adenocarcinoma, including neuro-endocrine dedifferentiation.
  • Oligoprogressive disease with up to 3 extracranial progressive lesions confirmed by imaging within 6 weeks before randomization.
  • Castration-refractory disease with testosterone level below 50 ng/dL.
  • Prior treatment of the primary tumor by radiotherapy or surgery; untreated primary tumors must be treated within the trial.
  • WHO performance status between 0 and 2.
  • Age 18 years or older.
  • No psychological, social, or geographical conditions that would make following the study difficult.
  • Approved for inclusion by a multidisciplinary tumor board.
Not Eligible

You will not qualify if you...

  • Diagnosed with ductal adenocarcinoma or small-cell prostate cancer.
  • Testosterone level above 50 ng/ml.
  • More than 3 progressive lesions or poly-progressive disease on imaging.
  • Presence of other active cancers that may affect trial results.
  • Previous treatments or health conditions making stereotactic body radiation therapy impossible.
  • Spinal bone lesions that are highly symptomatic, neurologically threatening, or at risk of fracture.
  • Prior treatment with radionuclides, cabazitaxel, or PARP inhibitors.
  • Disease progression while receiving docetaxel.
  • Unable to understand the treatment plan or provide informed consent.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Belgium

Actively Recruiting

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Research Team

K

Kato Rans, MD

CONTACT

G

Gert De Meerleer, 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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