NCT05884632Recruiting
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 1 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 23 May 2023
- Start date
- 3 Apr 2023
- Primary completion date
- 30 Apr 2030
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Diseases
- Prostate cancer
- NCT number
- NCT05884632
What you commit to
- Study type: Interventional
- Planned participants: 184
- From 3 Apr 2023 to the primary completion date, 30 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adjuvant radiotherapy;
- Previous radiation in the same anatomical site.
Age
- Age \<18 years old;
Who the study is looking for
- 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 in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Sacro Cuore Don Calabria di Negrar Coordinator of this site? Confirm its status | Negrar | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.