ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0

NCT07407608 | Recruiting DMC

• 1 other identifier: ABRUPT 2.0
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Conditions

Prostate Cancer; Prostate Cancer (Adenocarcinoma); Prostate Cancer Non-Metastatic

Keywords

Unfavorable Prostate Tumors; Stereotactic Body Radiotherapy (SBRT); Volumetric Modulated Arc Therapy (VMAT); Prostate Imaging Reporting and Data System (PI-RADS); Toxicity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Number of participants with acute genitourinary treatment-related adverse events as assessed by CTCAE v.5.0

  The primary endpoint is the cumulative incidence of acute CTCAE v5.0 grade ≥2 genitourinary (GU) toxicity from the start of radiotherapy to 3 months post-treatment. Toxicity assessments are performed at baseline, end of treatment, and at 1, 2, and 3 months after radiotherapy.

  3 months

Secondary Outcomes (7)

• Number of participants with late genitourinary treatment-related adverse events as assessed by CTCAE v.5.0

  1, 2 and 5 years

• Number of participants with treatment-related adverse gastrointestinal events as assessed by CTCAE v.5.0

  3 months, 1, 2 and 5 years

• QUALITY OF LIFE (QOL) assessed by EORTC QLQ-C30. For QoL domain minimum score (=0) means worst QoL and maximum score (=100) means best QoL.

  3 months, 1, 2 and 5 years

• Number of participants with voiding symptoms assessed by International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)

  3 months, 1, 2 and 5 years

• Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best)

  2 and 5 years

Study Arms (2)

5 Fx SBRT

Patients will receive 36.25 Gy SBRT in five fractions over two weeks

Radiation: SBRT

1 Fx SDRT

Patients will receive 24 Gy SDRT with urethra-sparing and a focal isotoxic GTV boost up to 27 Gy

Radiation: SDRT

Interventions

SBRT RADIATION

Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.

5 Fx SBRT

SDRT RADIATION

Single Dose Radiation Therapy. Ultrahypofractionated radiotherapy.

1 Fx SDRT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA \> 20 ng/mL allowed), as per NCCN definition

You may qualify if:

• Histologically proven prostate adenocarcinoma;
• Intermediate and High risk disease, as per the NCCN definition;
• a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI (mpMRI);
• N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) PSMA PET-CT;
• World Health Organization performance status 0-1;
• Life expectancy of \> 5 years, in the opinion of the investigator;
• IPSS score must be ≤ 15 (alpha blockers allowed);
• Prostate gland volume ≤100 g as estimated by computed tomography (CT), ultrasound, or MRI.

You may not qualify if:

• ≥T3b disease according to the 8th AJCC classification;
• PSA\>20 ng/ml;
• Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) or transurethral resection;
• Previous radiotherapy to the pelvis;
• Presence of a periurethral dominant lesion;
• Previous invasive malignancy unless disease free for a minimum of 5 years;
• Active Crohn's Disease or Ulcerative Colitis;
• Presence of hip prostheses.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

Related Publications (7)

• Panizza D, Faccenda V, Ingraito C, Chissotti C, Ferrario F, Colciago RR, De Ponti E, Arcangeli S. Real-time monitoring and appropriate margin selection in linac-based prostate SBRT: Analysis of two different intrafraction motion monitoring systems. Med Phys. 2025 Aug;52(8):e18060. doi: 10.1002/mp.18060.

  PMID: 40802285 BACKGROUND

• Panizza D, Faccenda V, Lucchini R, Daniotti MC, Trivellato S, Caricato P, Pisoni V, De Ponti E, Arcangeli S. Intrafraction Prostate Motion Management During Dose-Escalated Linac-Based Stereotactic Body Radiation Therapy. Front Oncol. 2022 Apr 7;12:883725. doi: 10.3389/fonc.2022.883725. eCollection 2022.

  PMID: 35463373 BACKGROUND

• Panizza D, Faccenda V, Arcangeli S, De Ponti E. Treatment Optimization in Linac-Based SBRT for Localized Prostate Cancer: A Single-Arc versus Dual-Arc Plan Comparison. Cancers (Basel). 2023 Dec 19;16(1):13. doi: 10.3390/cancers16010013.

  PMID: 38201441 BACKGROUND

• Faccenda V, Panizza D, Daniotti MC, Pellegrini R, Trivellato S, Caricato P, Lucchini R, De Ponti E, Arcangeli S. Dosimetric Impact of Intrafraction Prostate Motion and Interfraction Anatomical Changes in Dose-Escalated Linac-Based SBRT. Cancers (Basel). 2023 Feb 10;15(4):1153. doi: 10.3390/cancers15041153.

  PMID: 36831496 BACKGROUND

• Draulans C, Haustermans K, Pos FJ, van der Heide UA, De Cock L, van der Voort van Zyp J, De Boer H, Smeenk RJ, Kunze-Busch M, Monninkhof EM, De Roover R, Isebaert S, Kerkmeijer LGW. Stereotactic body radiotherapy with a focal boost to the intraprostatic tumor for intermediate and high risk prostate cancer: 5-year efficacy and toxicity in the hypo-FLAME trial. Radiother Oncol. 2024 Dec;201:110568. doi: 10.1016/j.radonc.2024.110568. Epub 2024 Oct 2.

  PMID: 39362607 BACKGROUND

• Tree AC, Hinder V, Chan A, Tolan S, Ostler P, van der Voet H, Kancherla K, Loblaw A, Naismith O, Jain S, Martin A, Price D, Brand D, Chu W, Duffton A, Kelly P, O'Neill B, Staffurth J, Sasso G, Pugh J, Manning G, Brown S, Burnett S, Griffin C, Hall E, van As N; PACE Investigators. Intensity-modulated moderately hypofractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-C): early toxicity results from a randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2025 Jul;26(7):936-947. doi: 10.1016/S1470-2045(25)00205-0. Epub 2025 Jun 12.

  PMID: 40517778 BACKGROUND

• Arcangeli S, Chissotti C, Ferrario F, Lucchini R, Belmonte M, Purrello G, Colciago RR, De Ponti E, Faccenda V, Panizza D. Ablative Radiation Therapy for Unfavorable Prostate Tumors (ABRUPT): Preliminary Analysis of Toxicity and Quality of Life from a Prospective Study. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1394-1403. doi: 10.1016/j.ijrobp.2024.06.030. Epub 2024 Jul 4.

  PMID: 38971384 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Stefano Arcangeli, MD

CONTACT

+39 039 233 3663; stefano.arcangeli@unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2034
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

IT (1)