Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Sacro Cuore Don Calabria di Negrar
RECRUITING
Negrar
Contact Information
Primary
Elvia Malo
ricerca.clinica@sacrocuore.it
+390456014854
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 184
Treatments
Experimental: Treatment arm
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
Related Therapeutic Areas
Sponsors
Leads: IRCCS Sacro Cuore Don Calabria di Negrar

This content was sourced from clinicaltrials.gov