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

RECRUITINGPhase 2Sponsored by Universitaire Ziekenhuizen KU Leuven
Actively Recruiting
PhasePhase 2
SponsorUniversitaire Ziekenhuizen KU Leuven
Started2017-02-06
Est. completion2025-02-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT03079323

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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