Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT03079323

Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

137

Participants Needed

1

Research Sites

416 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Prospective non-randomized phase 2 trial to study the efficacy of additional elective para-aortic RT (PART) in pN1 patients compared to those who were historically treated with adjuvant whole pelvic radiotherapy (WPRT) alone.

CONDITIONS

Official Title

Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and willingness to comply with the treatment and follow-up
  • Histopathologically confirmed prostate cancer diagnosis
  • No previous treatment for prostate cancer
  • Presence of pN1 disease after extended pelvic lymph node dissection (criteria defined in protocol)
  • Age over 18 years
  • Karnofsky Performance score greater than 70
  • Ability to understand and provide informed consent according to the Helsinki Declaration
Not Eligible

You will not qualify if you...

  • Recurrent prostate cancer
  • Presence of metastatic disease classified as cM1a, cM1b, or cM1c
  • Prior radiotherapy preventing whole pelvic or para-aortic radiotherapy
  • Previous malignancy not disease-free for more than 5 years, except basal cell skin cancer
  • Severe or active other illnesses likely to affect feasibility of radiotherapy
  • Cognitive or other disorders preventing understanding of trial information

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

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

G

Gert De Meerleer, Prof. Dr.

CONTACT

C

Charlien Berghen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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