Prostate CancerPhase 3PROPERNCT02745587
Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N+ Prostate Cancer.
A Phase 3 study testing radiotherapy in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2016to 22 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Willing to receive androgen deprivation therapy
- World health organization 0-2
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
high dose external beam radiotherapy limited to the prostate(bed)
| Study group | Role | What they receive |
|---|---|---|
| Prostate(bed) only | Experimental | external beam radiotherapy limited to the prostate(bed) Receives: Radiation: radiotherapy |
| Prostate(bed) and pelvis | Active comparator | external beam radiotherapy to the prostate(bed) and pelvic lymph node regions Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of number of participants without clinical relapse
presence of loco(regional) release or distant metastases
Measured: 8 years
Secondary outcomes (3)
Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity
acute
Measured: 5 years
Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity
late
Measured: 10 years
Assessment of number of participants with biochemical control
absence of prostate specific antigen relapse
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Jul 2021
- Study completion22 Sep 2022
Why it stopped: Stopped because of poor accrual in June 2021 after the inclusion of 69 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Fonteyne, Prof, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745587
- Sponsor's protocol ID
- 2016/0246
- Acronym
- PROPER
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2016
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The N+-PROPER Trial: Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N+ Prostate Cancer.
- ClinicalTrials.gov ID
- NCT02745587
- Acronym / sponsor ID
- PROPER / 2016/0246
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped because of poor accrual in June 2021 after the inclusion of 69 patients
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate(bed) only | Experimental | Radiation: radiotherapyexternal beam radiotherapy limited to the prostate(bed) |
| Prostate(bed) and pelvis | Active comparator | Radiation: radiotherapyexternal beam radiotherapy to the prostate(bed) and pelvic lymph node regions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyhigh dose external beam radiotherapy limited to the prostate(bed) | Radiation | Prostate(bed) and pelvis, Prostate(bed) only |
Primary outcome
Assessment of number of participants without clinical relapse
Time frame: 8 years
presence of loco(regional) release or distant metastases
3 secondary outcomes
Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity
Time frame: 5 years
Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity
Time frame: 10 years
Assessment of number of participants with biochemical control
Time frame: 8 years
Results and safety
The study was stopped early (reason given: Stopped because of poor accrual in June 2021 after the inclusion of 69 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Fonteyne, Prof principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiotherapy in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Stopped because of poor accrual in June 2021 after the inclusion of 69 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of number of participants without clinical relapse (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.