Last reviewed · How we verify
NCT04831970: POPART
POst-Prostatectomy Ablative Radiation Therapy
trial in Radiation Toxicity in 30 participants. Currently enrolling.
30 April 2026
Quick facts
| Lead sponsor | University of Milano Bicocca |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 15 April 2021 |
| Primary completion | 30 April 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across Italy |
Conditions studied
- Radiation Toxicity — all drugs for Radiation Toxicity →
Sponsor
University of Milano Bicocca
Who can join
Adults 18 to 90, male only, with Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (\< 90 days from the end of treatment) and late (\> 90 days) setting.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial.
Lucchini R, Franzese C, Vukcaj S, Purrello G, et al · · 2022 · cited 8× · PMID 36547147 · DOI 10.3390/curroncol29120733 -
Patient-Reported Outcomes With Stereotactic Intensity Modulated Radiotherapy After Radical Prostatectomy: A Nonrandomized Clinical Trial.
Nikitas J, Ballas LK, Romero T, Lynch C, et al · · 2025 · cited 6× · PMID 40372727 · DOI 10.1001/jamaoncol.2025.1059 -
Toxicity profile and Patient-Reported outcomes following salvage Stereotactic Ablative Radiation Therapy to the prostate Bed: The POPART multicentric prospective study.
Ferrario F, Franzese C, Faccenda V, Vukcaj S, et al · · 2024 · cited 5× · PMID 38111610 · DOI 10.1016/j.ctro.2023.100704 -
Image-Guided Stereotactic Body Radiotherapy on Detectable Prostate Bed Recurrence after Prostatectomy in RT-Naïve Patients.
Santamaria R, Zaffaroni M, Vincini MG, Colombi L, et al · · 2024 · cited 2× · PMID 39063623 · DOI 10.3390/life14070870
Verify or expand the search:
- PubMed search for NCT04831970
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04831970 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Milano Bicocca
- Last refreshed: 25 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04831970.
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