Prostate Cancer (Post Prostatectomy)SUPERBNCT06941363
Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
An observational study of Prostate Cancer (Post Prostatectomy), run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- SDRT
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2025to May 2033
- 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: Patients with biochemical relapse following radical prostatectomy
Who may be able to join
- Subjects of male sex ≥ 18 years of age.
- Subjects have freely signed the pertinent informed consent before the beginning of the study
- Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
- Detectable post-prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable)
- No evidence of N1 and/or M1 disease assessed by PSMA PET-CT within 90 days prior to registration
- Negative Magnetic Resonance Imaging (MRI) of the pelvis in case of equivocal evidence of local relapse on PSMA PET-CT
Show all 9Show fewer
- Androgen deprivation therapy (ADT) allowed as per physician's discretion
- ECOG performance status of 0-1
- Ability to complete the questionnaires
Who cannot join
- N1 and or M1 patients
- Macroscopic local relapse at pelvic MRI.
- Prior radiation of any kind to the prostate gland or pelvis
- Prior brachytherapy
- History of inflammatory colitis or other active severe comorbidities
- Patients who are on immunosuppressant medication
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 (University of Milan Bicocca)
Monza, Italy, 20900
Stefano Arcangeli, MD, +39 0392333663, stefano.arcangeli@unimib.it
About this study
Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility
Read the detailed description
Patients enrolled in this observational prospective trial undergo image-guided (IGRT) with volumetric-modulated arc radiotherapy (VMAT) using the same equipment, techniques, and treatment-planning procedures as per clinical practice. Eligible patients are those with persistently detectable PSA post-operatively or those developing biochemical recurrence after prostatectomy with initially undetectable PSA, without evidence of macroscopic local relapse and/or regional and distant metastases at restaging.
This trial aims to assess the toxicity profile of salvage single-fraction stereotactic radiotherapy (RT) to the prostate bed delivered using an IGRT-VMAT technique. The study is conducted using a two-stage design consisting of an initial dose-finding phase followed by a dose-expansion phase.
Stage 1 - Dose escalation and interim safety analysis. In the first stage, a rolling six dose-escalation design is used to evaluate the safety of 15 Gy, 16 Gy, and 17 Gy, each delivered in a single fraction. Patients are enrolled in cohorts of 3 to 6 patients per dose level. In accordance with the rolling six design, no more than six patients may be concurrently enrolled at a given dose level and considered at risk for dose-limiting toxicity (DLT) during the 90-day evaluation period.
The objective of this stage is to identify the maximum tolerated dose (MTD), defined as the highest dose associated with ≤1 DLT among 6 evaluable patients, with DLT defined as any grade ≥3 toxicity occurring within 90 days from treatment.
An interim safety analysis is planned after approximately 18 patients (ideally 6 per dose level) have been treated and evaluated.
Stage 2 - Dose expansion. Following the interim analysis, the study proceeds with a dose-expansion phase, enrolling additional patients to reach a total sample size of 50 patients. If all three dose levels are deemed tolerable, they will all be carried forward into this expansion phase in a balanced manner.
The sample size of 50 patients was calculated to provide a statistical power of 91.1% for the GU endpoint and 92.9% for the GI endpoint, with a two-sided alpha level of 0.05. The overall statistical power to reject the null hypothesis across both endpoints is 84.6%.
The null hypothesis (H₀) is based on acute toxicity rates reported in the NRG-GU003 phase III randomized trial for the hypofractionated post-prostatectomy radiotherapy (HYPORT) arm, which reported ≥G2 toxicity rates of 31.0% for GU and 22.5% for GI toxicity. The alternative hypothesis (H₁) is derived from prior studies of stereotactic body radiotherapy (SBRT) in the salvage setting, including the POPART and SCIMITAR trials, assuming toxicity rates of 12% for GU and 6% for GI toxicity.
Primary and secondary endpoints will be evaluated across the entire expanded cohort.
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- SDRT
- Keywords
- biochemical recurrence; salvage RT; toxicity profile; oncological outcomes; linac-based SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDRTRadiation
Salvage Single Dose Radiation Therapy (SDRT) to the prostate bed up to 17 Gy
| Study group | Role | What they receive |
|---|---|---|
| 1 fx SDRT | Not described 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 treatment-related adverse events as assessed by CTCAE v. 5.0
To prospectively evaluate the cumulative incidence of acute (< 90 days from the end of treatment) genitourinary (GU) and gastrointestinal (GI) treatment-related toxicities and adverse events. Toxicity assessments are performed at baseline, end of treatment, and at 1, 2, and 3 months after radiotherapy.
Measured: 3 months
Secondary outcomes (5)
Number of participants with late treatment-related adverse events as assessed by CTCAE v.5.0
To prospectively evaluate the cumulative incidence of late (≥ 6 months) genitourinary (GU) and gastrointestinal (GI) treatment-related toxicities and adverse events.
Measured: 1, 2 and 5 years
QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-CP) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL
To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-CP Questionnaire
Measured: 3 months, 1, 2 and 5 years
Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst)
To assess urinary continence after postoperative SDRT using ICIQ-SF
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 after postoperative SDRT using IIEF 5
Measured: 3 months, 1, 2 and 5 years
Number of participants with biochemical relapse assessed by PSA (cut off 0.20 ng/mL)
To assess biochemical outcome after postoperative SDRT using serum PSA levels
Measured: 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 posted23 Apr 2025
- Study start2 May 2025
- Primary completionMay 2033 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies 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
- 50 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
- NCT06941363
- Sponsor's protocol ID
- SUPERB
- Acronym
- SUPERB
- Status last verified
- Jan 2026
- First submitted
- 15 Apr 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma TM, Ballas LK, Wilhalme H, Sachdeva A, Chong N, Sharma S, Yang T, Basehart V, Reiter RE, Saigal C, Chamie K, Litwin MS, Rettig MB, Nickols NG, Yoon SM, Smith L, Gao Y, Steinberg ML, Cao M, Kishan AU. Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):142-152. doi: 10.1016/j.ijrobp.2022.08.041. Epub 2022 Aug 23.
PubMed 36007724Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109.
PubMed 32215583Burdett S, Fisher D, Parker CC, et al. LBA64 duration of androgen suppression with post-operative radiotherapy (DADSPORT): a collaborative meta-analysis of aggregate data. Ann Oncol. 2022;33(7):S1428-S1429
Ferrario F, Franzese C, Faccenda V, Vukcaj S, Belmonte M, Lucchini R, Baldaccini D, Badalamenti M, Andreoli S, Panizza D, Magli A, Scorsetti M, Arcangeli S. Toxicity profile and Patient-Reported outcomes following salvage Stereotactic Ablative Radiation Therapy to the prostate Bed: The POPART multicentric prospective study. Clin Transl Radiat Oncol. 2023 Nov 25;44:100704. doi: 10.1016/j.ctro.2023.100704. eCollection 2024 Jan.
PubMed 38111610Lucchini R, Franzese C, Vukcaj S, Purrello G, Panizza D, Faccenda V, Andreoli S, Poli GL, Baldaccini D, Lo Faro L, Tomatis S, Cazzaniga LF, Scorsetti M, Arcangeli S. Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial. Curr Oncol. 2022 Nov 30;29(12):9349-9356. doi: 10.3390/curroncol29120733.
PubMed 36547147Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291.
PubMed 38483412
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
- ClinicalTrials.gov ID
- NCT06941363
- Acronym / sponsor ID
- SUPERB / SUPERB
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Keywords
- biochemical recurrence; salvage RT; toxicity profile; oncological outcomes; linac-based SBRT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- May 2033 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 23 Apr 2025 (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.
Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility
Detailed description
Patients enrolled in this observational prospective trial undergo image-guided (IGRT) with volumetric-modulated arc radiotherapy (VMAT) using the same equipment, techniques, and treatment-planning procedures as per clinical practice. Eligible patients are those with persistently detectable PSA post-operatively or those developing biochemical recurrence after prostatectomy with initially undetectable PSA, without evidence of macroscopic local relapse and/or regional and distant metastases at restaging.
This trial aims to assess the toxicity profile of salvage single-fraction stereotactic radiotherapy (RT) to the prostate bed delivered using an IGRT-VMAT technique. The study is conducted using a two-stage design consisting of an initial dose-finding phase followed by a dose-expansion phase.
Stage 1 - Dose escalation and interim safety analysis. In the first stage, a rolling six dose-escalation design is used to evaluate the safety of 15 Gy, 16 Gy, and 17 Gy, each delivered in a single fraction. Patients are enrolled in cohorts of 3 to 6 patients per dose level. In accordance with the rolling six design, no more than six patients may be concurrently enrolled at a given dose level and considered at risk for dose-limiting toxicity (DLT) during the 90-day evaluation period.
The objective of this stage is to identify the maximum tolerated dose (MTD), defined as the highest dose associated with ≤1 DLT among 6 evaluable patients, with DLT defined as any grade ≥3 toxicity occurring within 90 days from treatment.
An interim safety analysis is planned after approximately 18 patients (ideally 6 per dose level) have been treated and evaluated.
Stage 2 - Dose expansion. Following the interim analysis, the study proceeds with a dose-expansion phase, enrolling additional patients to reach a total sample size of 50 patients. If all three dose levels are deemed tolerable, they will all be carried forward into this expansion phase in a balanced manner.
The sample size of 50 patients was calculated to provide a statistical power of 91.1% for the GU endpoint and 92.9% for the GI endpoint, with a two-sided alpha level of 0.05. The overall statistical power to reject the null hypothesis across both endpoints is 84.6%.
The null hypothesis (H₀) is based on acute toxicity rates reported in the NRG-GU003 phase III randomized trial for the hypofractionated post-prostatectomy radiotherapy (HYPORT) arm, which reported ≥G2 toxicity rates of 31.0% for GU and 22.5% for GI toxicity. The alternative hypothesis (H₁) is derived from prior studies of stereotactic body radiotherapy (SBRT) in the salvage setting, including the POPART and SCIMITAR trials, assuming toxicity rates of 12% for GU and 6% for GI toxicity.
Primary and secondary endpoints will be evaluated across the entire expanded cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 fx SDRT | – | Radiation: SDRT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biochemical relapse following radical prostatectomy
Key inclusion criteria (9 listed)
- Subjects of male sex ≥ 18 years of age.
- Subjects have freely signed the pertinent informed consent before the beginning of the study
Key exclusion criteria (6 listed)
- N1 and or M1 patients
- Macroscopic local relapse at pelvic MRI.
- Prior radiation of any kind to the prostate gland or pelvis
- Prior brachytherapy
- History of inflammatory colitis or other active severe comorbidities
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 |
|---|---|---|
| SDRTSalvage Single Dose Radiation Therapy (SDRT) to the prostate bed up to 17 Gy | Radiation | 1 fx SDRT |
Primary outcome
Number of participants with acute treatment-related adverse events as assessed by CTCAE v. 5.0
Time frame: 3 months
To prospectively evaluate the cumulative incidence of acute (< 90 days from the end of treatment) genitourinary (GU) and gastrointestinal (GI) treatment-related toxicities and adverse events. Toxicity assessments are performed at baseline, end of treatment, and at 1, 2, and 3 months after radiotherapy.
5 secondary outcomes
Number of participants with late treatment-related adverse events as assessed by CTCAE v.5.0
Time frame: 1, 2 and 5 years
QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-CP) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL
Time frame: 3 months, 1, 2 and 5 years
Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (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: 3 months, 1, 2 and 5 years
Number of participants with biochemical relapse assessed by PSA (cut off 0.20 ng/mL)
Time frame: 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 2 Feb 2026.
- Background: PubMed 36007724Ma TM, Ballas LK, Wilhalme H, Sachdeva A, Chong N, Sharma S, Yang T, Basehart V, Reiter RE, Saigal C, Chamie K, Litwin MS, Rettig MB, Nickols NG, Yoon SM, Smith L, Gao Y, Steinberg ML, Cao M, Kishan AU. Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):142-152. doi: 10.1016/j.ijrobp.2022.08.041. Epub 2022 Aug 23.
- Background: PubMed 32215583Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109.
- BackgroundBurdett S, Fisher D, Parker CC, et al. LBA64 duration of androgen suppression with post-operative radiotherapy (DADSPORT): a collaborative meta-analysis of aggregate data. Ann Oncol. 2022;33(7):S1428-S1429
- Background: PubMed 38111610Ferrario F, Franzese C, Faccenda V, Vukcaj S, Belmonte M, Lucchini R, Baldaccini D, Badalamenti M, Andreoli S, Panizza D, Magli A, Scorsetti M, Arcangeli S. Toxicity profile and Patient-Reported outcomes following salvage Stereotactic Ablative Radiation Therapy to the prostate Bed: The POPART multicentric prospective study. Clin Transl Radiat Oncol. 2023 Nov 25;44:100704. doi: 10.1016/j.ctro.2023.100704. eCollection 2024 Jan.
- Background: PubMed 36547147Lucchini R, Franzese C, Vukcaj S, Purrello G, Panizza D, Faccenda V, Andreoli S, Poli GL, Baldaccini D, Lo Faro L, Tomatis S, Cazzaniga LF, Scorsetti M, Arcangeli S. Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial. Curr Oncol. 2022 Nov 30;29(12):9349-9356. doi: 10.3390/curroncol29120733.
- Background: PubMed 38483412Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291.
- 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 (Post Prostatectomy), 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 9 inclusion and 6 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 2 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 0392333663, 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 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 NCT06941363, which also lists 6 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 2 Feb 2026.