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Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

NCT05352178 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 873

Last updated 2024-07-03

No results posted yet for this study

Summary

The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.

Conditions

  • Prostate Cancer
  • Prostate Cancer Recurrent
  • Prostate Cancer Metastatic
  • Metastatic Cancer
  • Oligometastatic Disease
  • Oligometastasis
  • Hormone Sensitive Prostate Cancer

Interventions

OTHER

Radiotherapy (SBRT) and/or surgery (metastasectomy)

Metastasis-directed therapay (surgery and/or radiotherapy) as treatment for oligorecurrent lesions

DRUG

Androgen deprivation therapy

Arm B: gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im Arm C: gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im

DRUG

Androgen receptor targeted therapy

Enzalutamide

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2027-04-25
Completion
2032-04-25

Countries

  • Belgium

Study Locations

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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 NCT05352178 on ClinicalTrials.gov