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Clinical Trials in Italy / NCT05557604
Recruiting Phase 2

Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

NCT05557604 · tracked via the Priya Life Science Italy tracker
Sponsor
Regina Elena Cancer Institute
Phase
Phase 2
Started
2021-02-02
Last updated
2022-09-28

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Decapeptyl →

Decapeptyl: STAD androgen deprivation

Study summary

This is a prospective, open, randomized phase II trial.

Eligibility

Sex
MALE
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically proven prostate adenocarcinoma * IR or HR in the NCCN definition * N0M0 at staging with choline or (preferably) PSMA PET-CT; * ECOG performance status between 0 and 2; Exclusion Criteria: * Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) * Previous radiotherapy to the pelvis * Previous chemotherapy for malignancy in past 5 years * Impossibility to implant fiducials for tracking purposes * Impossibility to undergo MRI of the prostate * Contraindication to short term AD * Prostate volume \>90cc

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Ifo Regina elena Rome Lazio Recruiting
ifo Regina Elena Rome RM Recruiting
Regina Elena National Cancer Institute Rome Italy Recruiting

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Other trials for the same condition

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr Recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM Recruiting
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer Active, not recruiting
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Active, not recruiting
Official registry record

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.

View NCT05557604 on ClinicalTrials.gov ↗ ← All trials in Italy