Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N+ Prostate Cancer. (PROPER)

December 23, 2022 updated by: University Hospital, Ghent

The N+-PROPER Trial: Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N+ Prostate Cancer.

At least 40% of the patients with prostate cancer (PC) present with positive lymph nodes (N1). The optimal treatment strategy for these patients remains controversial. Although androgen deprivation therapy (ADT) is still often initiated as only treatment, the results are disappointing. Recent studies support the use of more aggressive therapies including external beam radiotherapy (EBRT) and ADT. The retrospective studies supporting the additional use of EBRT in N1 PC patients are however not conclusive regarding to the extent of radiation field.

Even after an EPLND, there might be a role for pelvic EBRT in irradicating microscopic disease. However pelvic irradiation irrevocably results in increased toxicity. Moreover, in node negative (N0) PC patients the addition of pelvic EBRT has not resulted in improved outcome in randomised trials. However in the setting of Tumor Node Metastasis pathological stage (p)N1, proven on pathological examination, PC patients this has never been evaluated so far. This trial aims to answer the question whether or not pelvic EBRT is beneficial in pathological N1 PC patients. It is also important to realise that not all pathological N1 PC patients have similar outcome. There is a significant impact of number of positive lymph nodes on outcome, with two positive nodes being suggested as a significant cut-off value in predicting survival in pathological N1 PC patients. By stratifying the patients according to the number of lymph nodes involved this study will add to the proper selection of those patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no benefit of pelvic EBRT.

Additionally, small RNAs constitute potentially valuable markers for the diagnosis, prognosis, and therapeutic choices in PC patients. Blood samples will be collected to examine the potential role of miRNAs as a biomarker and to develop a prognostic signature for clinical relapse-free survival.

The results of this trial will serve as a base for developping new trials in order to optimise the treatment of patients with pathological N1 PC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In an era with increasing evidence in favour of an aggressive local treatment, where an extended pelvic lymph node dissection (EPLND) is more frequently performed and with data supporting the potential role for external beam radiotherapy (EBRT) in pelvic node positive (N1) prostate cancer (PC), the treatment of N1 PC patients needs to be revised. Seen the lack of clear guidelines regarding the extent of radiation field in N1 prostate cancer patients, there is an urgent need for studies evaluating the place of pelvic EBRT.

The aim of this trial is thus to evaluate if pelvic irradiation has an impact on clinical relapse free survival in pathological N1 PC.

The hypothesis is that performing a pelvic EBRT after EPLND in pathological N1 PC patients results in a significant improved clinical relapse free survival with 15% when compared to prostate only EBRT.

This will be evaluated in a multicentre Phase III stratified randomised trial randomising patients with PC and 1-4 positive lymph nodes on EPLND between prostate(bed) only radiotherapy + 2 years of ADT or pelvic radiotherapy + 2 years of androgen deprivation. A total of 330 patients will be enrolled in this trial. Stratification is based on the number of positive lymph nodes since patients with increased number of positive lymph nodes exhibit a poorer prognosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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, 9000
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histological proven carcinoma of the prostate
  • Positive lymph nodes found on extended pelvic dissection (EPLND) defined as:
  • Removal of the lymphatic tissue in the obturator fossa + along the external iliac vessels + additional complete resection of the lymph nodes (lnn) along, medially and laterally to, the hypogastric vessels
  • If technically feasible: removal of lnn along the common iliac vessels
  • Removal of ≥10 lnn
  • Treatment of the primary tumor by either radical prostatectomy or EBRT
  • Willing to receive androgen deprivation therapy
  • World health organization 0-2
  • Written informed consent

Exclusion Criteria:• >4 positive lnn found on EPLND

  • Prior pelvic irradiation
  • Other primary tumor (except for non-melanoma skin tumors) diagnosed <5 years before enrollment
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prostate(bed) only
external beam radiotherapy limited to the prostate(bed)
Radiation: radiotherapy
high dose external beam radiotherapy limited to the prostate(bed)
Active Comparator: Prostate(bed) and pelvis
external beam radiotherapy to the prostate(bed) and pelvic lymph node regions
Radiation: radiotherapy
high dose external beam radiotherapy limited to the prostate(bed)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of number of participants without clinical relapse
Time Frame: 8 years
presence of loco(regional) release or distant metastases
8 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity
Time Frame: 5 years
acute
5 years
Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity
Time Frame: 10 years
late
10 years
Assessment of number of participants with biochemical control
Time Frame: 8 years
absence of prostate specific antigen relapse
8 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valérie Fonteyne, Prof, University Hospital, Ghent

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/0246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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