Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer

September 1, 2023 updated by: University Hospital, Ghent

Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial

Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are conventionally treated with androgen deprivation therapy. However, in patients with limited metastatic load, the time to progression might be. Subsequently, active surveillance of these patients until progression might defer the start of androgen deprivation therapy (ADT) for several months to years. As an alternative, salvage treatment of the limited number of metastases with either surgery or radiotherapy might postpone the start of ADT even longer. The current trial hypothesizes that ADT might be deferred longer following salvage treatment as compared to active surveillance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven diagnosis of prostate cancer (PCa)
  • Biochemical relapse of PCa following radical local prostate treatment
  • N1 and M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
  • World Health Organization (WHO) performance state 0-1
  • Exclusion of local relapse
  • Age >=18 years old
  • Signed informed consent

Exclusion Criteria:

  • Serum testosterone level <50ng/ml
  • Symptomatic metastases
  • PSA rise while on active treatment with luteinizing hormone-releasing hormone (LHRH)-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen
  • Previous treatment with cytotoxic agent for PCa
  • Treatment during the past month with products known to influence Prostate Specific Antigen (PSA) levels (e.g. fluconazole, finasteride, corticosteroids,…)
  • Disorder precluding understanding of trial information or informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active clinical surveillance
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
Procedure: Surveillance
Active clinical surveillance
Experimental: Salvage treatment of metastases
Surgical or radiotherapy treatment of metastases.
Procedure: Salvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Androgen deprivation therapy free survival.
Time Frame: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.
Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.
From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life questionnaire 1.
Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months
Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)
At 3, 6, 9, 12, 15, 18, 21, 24 months
Quality of Life questionnaire 2.
Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months
Questionnaire: Short Form (36) Health Survey (SF36)
At 3, 6, 9, 12, 15, 18, 21, 24 months
Quality of life questionnaire 3
Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months
Questionnaire: EORTC QLQ PR25
At 3, 6, 9, 12, 15, 18, 21, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Gert De Meerleer, PhD, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimated)

March 20, 2012

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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