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Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer (PART)

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ClinicalTrials.gov Identifier: NCT03079323
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
Prospective non-randomized phase 2 trial to study the efficacy of additional elective para-aortic RT (PART) in pN1 patients compared to those who were historically treated with adjuvant whole pelvic radiotherapy (WPRT) alone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: PART-trial Phase 2

Detailed Description:

Rationale: In prostate cancer with histopathologically proven pelvic lymph node metastasis (pN1) after extended pelvic lymph node dissection, multimodality treatment consisting of treatment of the primary tumor, androgen deprivation therapy and whole pelvic radiotherapy offers the best results and is the standard-of-care. However, in case >1 pelvic lymph node is invaded by tumor, after extended pelvic lymph node dissection, 40% of the patients relapse biochemically and clinically. Clinical relapse is present in the para-aortic lymph nodes (M1a disease) in 25% of the cases as we observed in series. Therefore Elective Para-Aortic Radiotherapy (PART) may improve disease control.

Objective: The main goal of this phase II study is to investigate whether elective para-aortic radiotherapy increases the clinical relapse-free survival (cRFS) defined as the absence of clinical relapse (cR) at biological imaging at 5 years. The secondary objectives of this study are: acute toxicity, late toxicity, quality of life (QoL), time to palliative androgen deprivation therapy (ADT), time to castration refractory prostate cancer (CRPC), cause-specific survival and in field pelvic and para-aortic disease control.

Study design: The PART-trial is a non-randomized phase II trial.

Study population: Men with histological proven adenocarcinoma of the prostate (cT1-4; pT2-4) and presence of pN1 disease after ePLND are eligible for the study. For trial-inclusion, pN1 disease is defined on the basis of one of following criteria: (1) two or more positive LN; (2) ratio positive LN / removed LN > 7%; (3) presence of extracapsular LN extension. Patients referred for external beam radiotherapy (EBRT) who fulfill the inclusion criteria and without any of the exclusion criteria will be included in the present trial after written informed consent.

Intervention: Patients included in the PART-trial receive radiotherapy to the prostate or prostate bed and the pelvic lymph nodes according to the current standard. Furthermore patients in the PART-trial receive an additional elective radiation to the para-aortic lymph nodes. The total radiation dose that will be delivered to the para-aortic lymph node area is 45 Gy in 25 fractions of 1.8 Gy. Androgen deprivation therapy is foreseen in this trial for 24 months (long term).

Main study parameters/endpoints: The primary endpoint is to evaluate whether the addition of an elective para-aortic irradiation for pN1 prostate cancer patients increases the clinical relapse-free survival (cRFS) defined as the absence of clinical relapse (cR) at biological imaging at 5 years. Clinical relapse-free survival is defined by a combination of PSA measurements and imaging. Secondary endpoints are acute and late gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, QoL, time to palliative ADT, time to CRPC, cause-specific survival and in field pelvic and para-aortic disease control.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 137 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer Using Arc Therapy (IMAT/VMAT)
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: PART-trial
External beam radiotherapy
Radiation: PART-trial
Elective radiation to the para-aortic lymph nodes 45 Gy / 1.8 Gy




Primary Outcome Measures :
  1. Clinical relapse-free survival (cRFS) [ Time Frame: Median follow-up of 60 months ]
    The absence of clinical relapse (cR) at biological imaging


Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: Median follow-up of 90 days ]
    (CTCAE 4.0)

  2. Late toxicity [ Time Frame: Median follow-up of 3 years ]
    (CTCAE 4.0)

  3. Quality-of-life - General [ Time Frame: Median follow-up of 3 years ]
    EORTC QLQ-C30

  4. Quality-of-life - Prostate specific [ Time Frame: Median follow-up of 3 years ]
    EORTC QLQ-PR25

  5. Quality-of-life - Measure of health outcome [ Time Frame: Median follow-up of 3 years ]
    EQ-5D-5L

  6. Quality-of-life - Urinary incontinence [ Time Frame: Median follow-up of 3 years ]
    ICIQ-SF

  7. Quality-of-life - Erectile function [ Time Frame: Median follow-up of 3 years ]
    IIEF-5

  8. Time to palliative ADT [ Time Frame: Median follow-up of 5 years ]
    Indications for palliative ADT or based on the EAU guidelines

  9. Time to castration-refractory prostate cancer (CRPC) [ Time Frame: Median follow-up of 5 years ]
    Criteria for CRPC as defined in the EAU guidelines

  10. Cause-specific survival [ Time Frame: Median follow-up of 5 years ]
    Cause-specific survival

  11. Overall survival [ Time Frame: Median follow-up of 5 years ]
    Overall survival

  12. In field pelvic disease control (at biological imaging) [ Time Frame: Median follow-up of 5 years ]
    In field pelvic disease control (PET-CT imaging (PSMA/choline) is performed in case of PSA progression)

  13. In field PA disease control (at biological imaging) [ Time Frame: Median follow-up of 5 years ]
    In field PA disease control (PET-CT imaging (PSMA/choline) is performed in case of PSA progression)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent and willingness to comply with the treatment and follow-up
  • Diagnosis of histopathologically confirmed prostate cancer
  • No former treatment for prostate cancer
  • Presence of pN1 disease after ePLND (criteria defined in the protocol)
  • Age > 18
  • Karnofsky Performance score > 70
  • Ability to understand the informed consent (Helsinki Declaration)

Exclusion Criteria:

  • Recurrent disease status
  • Presence of cM1a, cM1b or cM1c disease
  • Former radiotherapy making WPRT and/or PART impossible
  • Prior malignancy, not disease-free > 5 years, except basocellular skin epithelioma
  • Severe or active comorbidity likely to impact on the feasibility of WPRT and/or PART
  • Disorder precluding understanding of trial information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079323


Contacts
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Contact: Gert De Meerleer, Prof. Dr. 00 32 16 34 76 00 gert.demeerleer@uzleuven.be
Contact: Charlien Berghen, MD 00 32 16 34 52 17 charlien.berghen@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Gert De Meerleer, Prof. Dr.    00 32 16 34 76 00    gert.demeerleer@uzleuven.be   
Contact: Charlien Berghen, MD    00 32 16 34 52 17    charlien.berghen@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Gert De Meerleer, Prof. Dr. UZ Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03079323     History of Changes
Other Study ID Numbers: S59533
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
External beam radiotherapy
Prostate cancer
Elective para-aortic radiation therapy
PART

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases