Prostate CancerProstate Cancer (Adenocarcinoma)Prostate Cancer Non-Metastatic
Investigational drug(s) / intervention(s)
SBRTSDRT
SBRT: Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
SDRT: Single Dose Radiation Therapy. Ultrahypofractionated radiotherapy.
Study summary
Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.
Eligibility
Sex
MALE
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically proven prostate adenocarcinoma;
* Intermediate and High risk disease, as per the NCCN definition;
* a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI (mpMRI);
* N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) PSMA PET-CT;
* World Health Organization performance status 0-1;
* Life expectancy of \> 5 years, in the opinion of the investigator;
* IPSS score must be ≤ 15 (alpha blockers allowed);
* Prostate gland volume ≤100 g as estimated by computed tomography (CT), ultrasound, or MRI.
Exclusion Criteria:
* ≥T3b disease according to the 8th AJCC classification;
* PSA\>20 ng/ml;
* Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) or transurethral resection;
* Previous radiotherapy to the pelvis;
* Presence of a periurethral dominant lesion;
* Previous invasive malignancy unless disease free for a minimum of 5 years;
* Active Crohn's Disease or Ulcerative Colitis;
* Presence of hip prostheses.
Primary outcome measure(s)
Number of participants with acute genitourinary treatment-related adverse events as assessed by CTCAE v.5.0 — 3 months The primary endpoint is the cumulative incidence of acute CTCAE v5.0 grade ≥2 genitourinary (GU) toxicity from the start of radiotherapy to 3 months post-treatment. Toxicity assessments are performed at baseline, end of treatment, and at 1, 2, and 3 months after radiotherapy.
Trial sites (1)
Facility
City
Region
Status
Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
