Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
ID: NCT05884632
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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.
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 Arms Description
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
- 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.
- Age \<18 years old;
- Adjuvant radiotherapy;
- Previous radiation in the same anatomical site.
Primary Outcome Measures
- Acute gastrointestinal toxicity — Time Frame: 90 days from the RT treatment
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.
View Secondary Outcome Measures (7)
- Acute genitourinary toxicity — Time Frame: 90 days from the RT treatment.
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment.
- Late toxicity — Time Frame: From 90 days after the RT treatment until 24 months
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment.
- QLQ-C30 — Time Frame: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
- Biochemical failure — Time Frame: 24 months
PSA raise after RT from nadir
- Time to biochemical failure — Time Frame: 24 months
Time between salvage RT and biochemical failure
- Local in-field relapse — Time Frame: 24 months
Local in-field relapse evaluated with PET-CT or RM
- Metastases-free survival — Time Frame: 24 months
Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients