ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-90
SponsorUniversity of Milano Bicocca
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
≥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;
Trial population
Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA \> 20 ng/mL allowed), as per NCCN definition
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SBRT
RadiationStereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
SDRT
RadiationSingle Dose Radiation Therapy. Ultrahypofractionated radiotherapy.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: 5 Fx SBRT1 intervention
Group B: 1 Fx SDRT1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with acute genitourinary treatment-related adverse events as assessed by CTCAE v.5.0
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.
Time frame
3 monthsSecondary outcomes
1
Number of participants with late genitourinary treatment-related adverse events as assessed by CTCAE v.5.0
To assess treatment related late genitourinary (GU) toxicity
Time frame
1, 2 and 5 years2
Number of participants with treatment-related adverse gastrointestinal events as assessed by CTCAE v.5.0
To assess treatment related gastrointestinal (GI) acute and late toxicity
Time frame
3 months, 1, 2 and 5 years3
QUALITY OF LIFE (QOL) assessed by EORTC QLQ-C30. For QoL domain minimum score (=0) means worst QoL and maximum score (=100) means best QoL.
To measure symptom scores for each QOL domain (overall QoL) by EORTC Questionnaire
Time frame
3 months, 1, 2 and 5 years4
Number of participants with voiding symptoms assessed by International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)
To assess voiding symptoms using IPSS
Time frame
3 months, 1, 2 and 5 yearsSponsors and contacts
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Source ClinicalTrials.gov