Prostate Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONDaily Adaptive RadioTherapy
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
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute gastrointestinal toxicity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late toxicity | 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 | 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 | 24 months | PSA raise after RT from nadir |
| Acute genitourinary toxicity | 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. |
| Local in-field relapse | 24 months | Local in-field relapse evaluated with PET-CT or RM |
| Metastases-free survival | 24 months | Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise |
| Time to biochemical failure | 24 months | Time between salvage RT and biochemical failure |
Countries
Italy
Contacts
Primary ContactElvia Malo
Outcome results
None listed