Local Treatment With RP for Newly-diagnosed mPCa

Last updated: December 19, 2023
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Neoplasm Metastasis

Prostate Cancer

Treatment

Radical Prostatectomy (RP)

Clinical Study ID

NCT02138721
B670201420709
  • Ages 18-85
  • Male

Study Summary

The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of prostate adenocarcinoma, confirmed by histology
  • Newly diagnosis of metastatic disease (stage TanyNanyM+)
  • Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
  • Written informed consent, male ≥18yo
  • Willing and expected to comply with study protocol and follow-up schedule
  • Multidisciplinary Oncologic Consultation (MOC) approval

Exclusion

Exclusion Criteria:

  • Previous local or systemic treatment for prostate cancer
  • Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
  • Symptoms clearly related to metastatic lesions
  • Any other previous or current (malignant) disease which, in the judgment of theresponsible physician, is likely to interfere with LoMP treatment or assessment

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Radical Prostatectomy (RP)
Phase:
Study Start date:
June 28, 2018
Estimated Completion Date:
December 31, 2024

Study Description

Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.

Study Groups:

After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done.

Follow-up:

Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care.

Routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. A CT-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when Castration Refractory PCa (CRPC) is established.

Androgen Deprivation Therapy (ADT) will be initiated in case of one of the following:

  • symptoms related to metastatic lesion(s)

  • Prostate Specific Antigen (PSA) > 50ng/ml and doubling time (PSA-DT) < 6 months (starting 3 months after inclusion at earliest)

The estimated number of patients to be included in the local treatment arm is 40.

Connect with a study center

  • ASZ Aalst

    Aalst,
    Belgium

    Active - Recruiting

  • Imelda Ziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • University Hospital, Ghent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • Sint-Fransiskusziekenhuis

    Heusden-Zolder,
    Belgium

    Active - Recruiting

  • AZ Jan Portaels

    Vilvoorde,
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.