MedTrace Logo

PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

NCT03569241 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-12-09

No results posted yet for this study

Summary

A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed.

The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions).

Conditions

Interventions

RADIATION

whole pelvic radiotherapy

addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment

RADIATION

metastasis-directed treatment

stereotactic body radiotherapy

PROCEDURE

salvage Lymph Node Dissection

metastasis-directed treatment

DRUG

androgen deprivation therapy

LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Piet Ost, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2023-04-30
Completion
2026-12-31

Countries

  • Australia
  • Belgium
  • Italy
  • Norway
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT03569241 on ClinicalTrials.gov