Daily adaptive radiotherapy for prostate cancer patients after surgery
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
This study is testing a new daily radiation treatment for men with prostate cancer that comes back after surgery to see if it causes less side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT05884632 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the treatment-related toxicity of a daily-adaptive hypofractionated postoperative salvage radiotherapy in patients with biochemical recurrence of prostate cancer. Participants will receive a total dose of 59 Gy in 20 fractions, with the treatment tailored daily based on individual patient responses. The study is monoinstitutional and will compare outcomes with existing literature rather than using a control group.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 80 with a diagnosis of prostate cancer who have undergone radical prostatectomy and are experiencing biochemical recurrence.
Not a fit: Patients with distant metastases, those under 18 years old, or those who have received prior radiation in the same area will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced toxicity and improved outcomes for prostate cancer patients undergoing salvage radiotherapy.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results with adaptive radiotherapy techniques in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \<18 years old; * Adjuvant radiotherapy; * Previous radiation in the same anatomical site.
Where this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria di Negrar — Negrar, Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Nicosia — IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata
- Study coordinator: Elvia Malo
- Email: ricerca.clinica@sacrocuore.it
- Phone: +390456014854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.