Clinical trial · Interventional
Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer
Phase II Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer Using Arc Therapy (IMAT/VMAT)
NCT03079323CI-TRIAL-00078534PARTunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PART-trial | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PART-trial
- description
- External beam radiotherapy
- interventionNames
- Radiation: PART-trial
Primary outcomes (1)
- measure
- Clinical relapse-free survival (cRFS)
- timeFrame
- Median follow-up of 60 months
- description
- The absence of clinical relapse (cR) at biological imaging
Secondary outcomes (13)
- measure
- Acute toxicity
- timeFrame
- Median follow-up of 90 days
- description
- (CTCAE 4.0)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDraulans 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