NCT03079323 Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer
| NCT ID | NCT03079323 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 137 participants |
| Start Date | 2017-02-06 |
| Primary Completion | 2025-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 137 participants in total. It began in 2017-02-06 with a primary completion date of 2025-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Gert De Meerleer, Prof. Dr.
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT03079323 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03079323 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03079323 currently recruiting?
Yes, NCT03079323 is actively recruiting participants. Contact the research team at gert.demeerleer@uzleuven.be for enrollment information.
Where is the NCT03079323 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT03079323 clinical trial?
NCT03079323 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Gert De Meerleer, Prof. Dr. at UZ Leuven. The trial plans to enroll 137 participants.
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