Prostate CancerABRUPT 2NCT07407608
ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0
An observational study of Prostate Cancer and Prostate Cancer (Adenocarcinoma), run by University of Milano Bicocca at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer (Adenocarcinoma), Prostate Cancer Non-Metastatic
- What is being tested?
- SBRT and SDRT
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2026to 31 Jul 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA > 20 ng/mL allowed), as per NCCN definition
Who may be able to join
- 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.
Who cannot join
- ≥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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Stefano Arcangeli, MD, +39 039 233 3663, stefano.arcangeli@unimib.it
About this study
Official title: Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer
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.
Read the detailed description
ABRUPT 2.0 is a non-comparative, randomized phase II trial focusing on acute genitourinary (GU) toxicity as the primary endpoint in a similar patient population. Acute GU toxicity was selected because it has been shown to be predictive of late GU toxicity and represents a clinically meaningful early safety endpoint. Using PACE-C as a benchmark, the trial is designed to test the hypothesis that acute GU toxicity in each treatment arm will remain within predefined clinically acceptable limits. Patients are randomized in a 1:1 ratio to receive either 36.25 Gy SBRT in five fractions over two weeks or 24 Gy SDRT with urethra-sparing and a focal isotoxic GTV boost up to 27 Gy. Randomization is performed using a minimization algorithm balanced for NCCN risk group (intermediate-unfavorable vs selected high-risk) and incorporating a random element. Treatment allocation is not masked. All participants are treated at a single institution (Fondazione IRCCS San Gerardo dei Tintori and University of Milan-Bicocca).
All patients undergo non-contrast-enhanced CT and mpMRI simulation on the same day. Anatomic reproducibility is ensured through rectal micro-enema administration. In the SDRT arm, the bladder is filled with 150 mL of saline solution via a 16-F Foley catheter before simulation and treatment delivery. In the five-fraction SBRT arm, bladder preparation consists of drinking 500 mL of still water 30-45 minutes before simulation and each fraction. The use of a hyaluronic acid rectal spacer is encouraged and left at physician's discretion. Patients are positioned supine with arms placed over the chest. CT images and T2-weighted 3D MRI scans are fused for target and OAR delineation. The GTV was defined as the visible tumor lesion on mpMRI in collaboration with an experienced radiologist. The clinical target volume (CTV) encompasses the entire prostate gland and seminal vesicles. The PTV is generated by applying a 3-mm isotropic margin to the CTV. OARs include the urethra, bladder, bladder trigone, rectum, femoral heads, penile bulb, bowel, and neurovascular bundles. In the SDRT arm, a 3-mm isotropic margin is added to the urethra, bladder, and rectum to generate planning OAR volumes (PRV), and the minimum prescribed dose to the GTV and PTV is constrained by OAR dose limits. In the five-fraction SBRT arm, the treatment prescription consists of 36.25 Gy administered in five fractions over two weeks on alternate days, with a mandatory additional CTV dose target of 40 Gy. Both dose levels are prescribed to the isodose covering 95% of the target volume, with controlled dose heterogeneity within the target and a maximum PTV dose of 42 Gy to protect the urethra by limiting its estimated dose to ≤95Gy EQD2. No focal boost is delivered to the GTV in this arm. In both arms, treatment plans are optimized using a 10-MV flattening-filter-free single partial arc (140°-220°), allowing a substantial reduction in treatment time.
In order to preserve identical 3-mm PTV margins in both treatment arms, continuous intrafraction motion monitoring is systematically implemented. Two distinct non-ionizing real-time tracking systems are employed. In the SDRT arm, prostate motion is monitored using an electromagnetic transmitter embedded within a urethral catheter. In the five-fraction SBRT arm, real-time tracking is performed using a 4D transperineal ultrasound system. All treatments are delivered on a linear accelerator. Initial patient positioning is verified using cone-beam CT with soft-tissue matching. Beam delivery is interrupted and patient positioning corrected whenever prostate displacement exceeds 2.5 mm in any of the three spatial directions.
The sample size has been determined using a Simon two-stage minimax design, independently powered for each treatment group to test whether the incidence of acute G2+ toxicity is significantly different from 51% (null hypothesis), using a one-sided 0.05-level test with 90% power to detect a true toxicity rate of 25%. Each group includes 29 patients (stage 1: 25 patients, and stage 2: 4 patients). The trial continued to complete stage 2 as 9 or fewer patients among the first 25 will develop G2+ GU toxicity within 3 months after treatment. If 10 patients or fewer in a group will develop G2+ GU toxicity, this would allow rejecting the null hypothesis of a 51% toxicity rate, which is 1.5 times higher than the rate observed in the PACE-C trial. Under the two-stage design, interim analysis will be provided after 10 patients are treated in each group to ensure that acute toxicity rates are within acceptable limits before proceeding to full accrual. The trial is not powered to detect statistical differences between the two treatment groups; therefore, data will be analysed descriptively.
- Being tested
- SBRT, SDRT
- 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
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
SDRTRadiation
Single Dose Radiation Therapy. Ultrahypofractionated radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 5 Fx SBRT | Patients will receive 36.25 Gy SBRT in five fractions over two weeks Receives: Radiation: SBRT | |
| 1 Fx SDRT | Patients will receive 24 Gy SDRT with urethra-sparing and a focal isotoxic GTV boost up to 27 Gy Receives: Radiation: SDRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
Number of participants with late genitourinary treatment-related adverse events as assessed by CTCAE v.5.0
To assess treatment related late genitourinary (GU) toxicity
Measured: 1, 2 and 5 years
Number of participants with treatment-related adverse gastrointestinal events as assessed by CTCAE v.5.0
To assess treatment related gastrointestinal (GI) acute and late toxicity
Measured: 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.
To measure symptom scores for each QOL domain (overall QoL) by EORTC Questionnaire
Measured: 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)
To assess voiding symptoms using IPSS
Measured: 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)
To assess erectile function using IIEF 5
Measured: 2 and 5 years
Number of participants with biochemical relapse assessed by PSA (Phoenix definition)
To assess biochemical outcome using serum PSA levels
Measured: 2 and 5 years
QUALITY OF LIFE (QOL) assessed by EORTC PR-25. For QoL domain minimum score (=0) means best QoL symptoms and maximum score (=100) means worst QoL symptoms
To measure symptom scores for each QOL domain (urinary incontinence and bowel dysfunction) by EORTC Questionnaire
Measured: 3 months, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start28 Jan 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Arcangeli, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407608
- Sponsor's protocol ID
- ABRUPT 2.0
- Acronym
- ABRUPT 2
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40802285Panizza 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.
PubMed 35463373Panizza 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.
PubMed 38201441Faccenda 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.
PubMed 36831496Draulans 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.
PubMed 39362607Tree 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.
PubMed 40517778Arcangeli 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.
PubMed 38971384
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT07407608
- Acronym / sponsor ID
- ABRUPT 2 / ABRUPT 2.0
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2034 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ABRUPT 2.0 is a non-comparative, randomized phase II trial focusing on acute genitourinary (GU) toxicity as the primary endpoint in a similar patient population. Acute GU toxicity was selected because it has been shown to be predictive of late GU toxicity and represents a clinically meaningful early safety endpoint. Using PACE-C as a benchmark, the trial is designed to test the hypothesis that acute GU toxicity in each treatment arm will remain within predefined clinically acceptable limits. Patients are randomized in a 1:1 ratio to receive either 36.25 Gy SBRT in five fractions over two weeks or 24 Gy SDRT with urethra-sparing and a focal isotoxic GTV boost up to 27 Gy. Randomization is performed using a minimization algorithm balanced for NCCN risk group (intermediate-unfavorable vs selected high-risk) and incorporating a random element. Treatment allocation is not masked. All participants are treated at a single institution (Fondazione IRCCS San Gerardo dei Tintori and University of Milan-Bicocca).
All patients undergo non-contrast-enhanced CT and mpMRI simulation on the same day. Anatomic reproducibility is ensured through rectal micro-enema administration. In the SDRT arm, the bladder is filled with 150 mL of saline solution via a 16-F Foley catheter before simulation and treatment delivery. In the five-fraction SBRT arm, bladder preparation consists of drinking 500 mL of still water 30-45 minutes before simulation and each fraction. The use of a hyaluronic acid rectal spacer is encouraged and left at physician's discretion. Patients are positioned supine with arms placed over the chest. CT images and T2-weighted 3D MRI scans are fused for target and OAR delineation. The GTV was defined as the visible tumor lesion on mpMRI in collaboration with an experienced radiologist. The clinical target volume (CTV) encompasses the entire prostate gland and seminal vesicles. The PTV is generated by applying a 3-mm isotropic margin to the CTV. OARs include the urethra, bladder, bladder trigone, rectum, femoral heads, penile bulb, bowel, and neurovascular bundles. In the SDRT arm, a 3-mm isotropic margin is added to the urethra, bladder, and rectum to generate planning OAR volumes (PRV), and the minimum prescribed dose to the GTV and PTV is constrained by OAR dose limits. In the five-fraction SBRT arm, the treatment prescription consists of 36.25 Gy administered in five fractions over two weeks on alternate days, with a mandatory additional CTV dose target of 40 Gy. Both dose levels are prescribed to the isodose covering 95% of the target volume, with controlled dose heterogeneity within the target and a maximum PTV dose of 42 Gy to protect the urethra by limiting its estimated dose to ≤95Gy EQD2. No focal boost is delivered to the GTV in this arm. In both arms, treatment plans are optimized using a 10-MV flattening-filter-free single partial arc (140°-220°), allowing a substantial reduction in treatment time.
In order to preserve identical 3-mm PTV margins in both treatment arms, continuous intrafraction motion monitoring is systematically implemented. Two distinct non-ionizing real-time tracking systems are employed. In the SDRT arm, prostate motion is monitored using an electromagnetic transmitter embedded within a urethral catheter. In the five-fraction SBRT arm, real-time tracking is performed using a 4D transperineal ultrasound system. All treatments are delivered on a linear accelerator. Initial patient positioning is verified using cone-beam CT with soft-tissue matching. Beam delivery is interrupted and patient positioning corrected whenever prostate displacement exceeds 2.5 mm in any of the three spatial directions.
The sample size has been determined using a Simon two-stage minimax design, independently powered for each treatment group to test whether the incidence of acute G2+ toxicity is significantly different from 51% (null hypothesis), using a one-sided 0.05-level test with 90% power to detect a true toxicity rate of 25%. Each group includes 29 patients (stage 1: 25 patients, and stage 2: 4 patients). The trial continued to complete stage 2 as 9 or fewer patients among the first 25 will develop G2+ GU toxicity within 3 months after treatment. If 10 patients or fewer in a group will develop G2+ GU toxicity, this would allow rejecting the null hypothesis of a 51% toxicity rate, which is 1.5 times higher than the rate observed in the PACE-C trial. Under the two-stage design, interim analysis will be provided after 10 patients are treated in each group to ensure that acute toxicity rates are within acceptable limits before proceeding to full accrual. The trial is not powered to detect statistical differences between the two treatment groups; therefore, data will be analysed descriptively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 Fx SBRT | – | Radiation: SBRTPatients will receive 36.25 Gy SBRT in five fractions over two weeks |
| 1 Fx SDRT | – | Radiation: SDRTPatients will receive 24 Gy SDRT with urethra-sparing and a focal isotoxic GTV boost up to 27 Gy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA > 20 ng/mL allowed), as per NCCN definition
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- ≥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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTStereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy. | Radiation | 5 Fx SBRT |
| SDRTSingle Dose Radiation Therapy. Ultrahypofractionated radiotherapy. | Radiation | 1 Fx SDRT |
Primary outcome
Number of participants with acute genitourinary treatment-related adverse events as assessed by CTCAE v.5.0
Time frame: 3 months
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.
7 secondary outcomes
Number of participants with late genitourinary treatment-related adverse events as assessed by CTCAE v.5.0
Time frame: 1, 2 and 5 years
Number of participants with treatment-related adverse gastrointestinal events as assessed by CTCAE v.5.0
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 2 and 5 years
Number of participants with biochemical relapse assessed by PSA (Phoenix definition)
Time frame: 2 and 5 years
QUALITY OF LIFE (QOL) assessed by EORTC PR-25. For QoL domain minimum score (=0) means best QoL symptoms and maximum score (=100) means worst QoL symptoms
Time frame: 3 months, 1, 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 40802285Panizza 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.
- Background: PubMed 35463373Panizza 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.
- Background: PubMed 38201441Panizza 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.
- Background: PubMed 36831496Faccenda 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.
- Background: PubMed 39362607Draulans 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.
- Background: PubMed 40517778Tree 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.
- Background: PubMed 38971384Arcangeli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Cancer (Adenocarcinoma), run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Arcangeli, MD (+39 039 233 3663, stefano.arcangeli@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute genitourinary treatment-related adverse events as assessed by CTCAE v.5.0 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07407608, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.