Daily adaptive radiotherapy for prostate cancer that has returned after surgery
Tests a short course of daily-adjusted radiation in men with prostate cancer returning after surgery.
Key facts
- Who runs it
- IRCCS Sacro Cuore Don Calabria di Negrar
- Where
- Negrar, ItalySee the site
- Trial code
- Registry title
- Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
- Status
- Recruiting
- People taking part
- 184 people, planned
- Started
- 3 Apr 2023
- Expected to end
- 30 Apr 2030
- Type of study
- Interventional
- Treatments tested
- Daily Adaptive RadioTherapy
- Record updated
- 1 June 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men up to 80 years old whose prostate cancer came back (rising PSA) after surgery and who need radiotherapy to the area where the prostate was.
- Age
- 18 to 80 years
- Sex
- Men only
- Disease stage
- Prostate cancer pT2-3 pN0, with any resection margin (R0 or R1), no distant metastases (M0) on PSMA-PET-CT, and an indication for local salvage radiotherapy after radical prostatectomy (PSA below 0.2 ng/ml or PSA 0.2 ng/ml or higher).
- Earlier treatment
- Must have had radical prostatectomy (prostate removal surgery). Cannot have had adjuvant radiotherapy or earlier radiation in the same area.
- Biomarker or test result
- PSA below 0.2 ng/ml (early salvage) or 0.2 ng/ml or higher (salvage); no distant metastases on PSMA-PET-CT.
Main reasons for not taking part
- Younger than 18 years
- Adjuvant radiotherapy
- Previous radiation in the same anatomical site
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Age ≤ 80 years
- Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1)
- Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml
- No distant metastases (M0) diagnosed with PSMA-PET-CT
- Informed consent to trial's participation and personal data treatment
Who cannot take part
- Adjuvant radiotherapy
- Previous radiation in the same anatomical site
- Age <18 years old
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- IRCCS Sacro Cuore Don Calabria di NegrarNegrar, ItalyContact: Luca Nicosia, DoctorTaking people
About the trial
What the trial wants to find out
This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.
Read full original descriptionShow less
Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.
The group in the trial
- Treatment armTreatment being tested
Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy
Treatment: Daily Adaptive RadioTherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
- Plain-language title
- Daily adaptive radiotherapy for prostate cancer that has returned after surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05884632, who can take part
- Record updated
- 1 June 2023