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

NCT03079323 | Recruiting Phase 2

• 1 other identifier: S59533
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

External beam radiotherapy; Prostate cancer; Elective para-aortic radiation therapy; PART

Outcome Measures

Primary Outcomes (1)

• Clinical relapse-free survival (cRFS)

  The absence of clinical relapse (cR) at biological imaging

  Median follow-up of 60 months

Secondary Outcomes (13)

• Acute toxicity

  Median follow-up of 90 days

• Late toxicity

  Median follow-up of 3 years

• Quality-of-life - General

  Median follow-up of 3 years

• Quality-of-life - Prostate specific

  Median follow-up of 3 years

• Quality-of-life - Measure of health outcome

  Median follow-up of 3 years

Study Arms (1)

PART-trial

EXPERIMENTAL

External beam radiotherapy

Radiation: PART-trial

Interventions

PART-trial RADIATION

Elective radiation to the para-aortic lymph nodes 45 Gy / 1.8 Gy

PART-trial

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• Draulans C, Joniau S, Fonteyne V, Delrue L, Decaestecker K, Everaerts W, Dirix P, Van den Bergh L, Crijns W, Vandendriessche H, Van Wynsberge L, Ost P, Lumen N, Buelens P, Haustermans K, Berghen C, De Meerleer G. Benefits of Elective Para-Aortic Radiotherapy for pN1 Prostate Cancer Using Arc Therapy (Intensity-Modulated or Volumetric Modulated Arc Therapy): Protocol for a Nonrandomized Phase II Trial. JMIR Res Protoc. 2018 Dec 13;7(12):e11256. doi: 10.2196/11256.

  PMID: 30545809 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gert De Meerleer, Prof. Dr.

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gert De Meerleer, Prof. Dr.

CONTACT

00 32 16 34 76 00; gert.demeerleer@uzleuven.be

Charlien Berghen, MD

CONTACT

00 32 16 34 52 17; charlien.berghen@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 14, 2017
• Study Start: February 6, 2017
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)