Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
Recruiting now · Not applicable
Conditions studied: Prostate Cancer
In brief
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. 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.
Key facts
- Study ID
- NCT05884632
- Run by
- IRCCS Sacro Cuore Don Calabria di Negrar
- People needed
- 184
- Starts
- 2023-04-03
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2023-06-01
Who can join
Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Age <18 years old;
- Adjuvant radiotherapy;
- Previous radiation in the same anatomical site.
Where it is running
- IRCCS Sacro Cuore Don Calabria di Negrar — Negrar, Verona, Italy (enrolling)
Full record on ClinicalTrials.gov
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