Image

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

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

Recruiting
18-90 years
Male
Phase 2
  • Technical (Original)
  • Simplified (AI rewritten)

Powered by AI

Overview

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

Description

Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

Eligibility

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

Study details
    Prostate Cancer

NCT05557604

Regina Elena Cancer Institute

26 January 2024

Contact a study center
Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.