Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06027892

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer

Led by Rabin Medical Center · Updated on 2024-11-15

562

Participants Needed

1

Research Sites

517 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized prostate cancer was given in small treatments over a period of multiple weeks. Recent studies have shown that with newer technologies and better understanding of how prostate cancer responds to radiation, the same effective dose can be given in as few as 5 treatments. This study is comparing this newer standard course of 5 treatments with an even shorter course of just 2 treatments. The dose for the 2 treatments is based on a form of internal radiation called brachytherapy, but in this study, that dose will be given using external radiation, without the need for invasive procedures. In order to make sure that the radiation therapy is given in a way that minimizes the risk of side effects to the surrounding organs, including the rectum and bladder, prior to radiation a hydrogel material will be inserted behind the prostate in order to distance the rectum further from the prostate gland, and small gold markers will be inserted into the prostate to decrease any possible movement during treatment. The main questions are whether 2-treatment radiation is tolerated as well and is as effective at treating prostate cancer, compared to the standard 5-treatment course of radiation.

CONDITIONS

Official Title

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Diagnosed with low- or favorable intermediate-risk prostate adenocarcinoma
  • Cancer stage T1 to T2c
  • Prostate specific antigen (PSA) less than 20
  • Gleason score 6 or 7 (3+4)
  • No multiple intermediate-risk factors indicating unfavorable intermediate risk disease
  • Prostate gland size less than 60 cc (including after cytoreductive androgen deprivation)
  • International Prostate Symptom Score less than 15 without use of a-adrenergic inhibitor or anticholinergic drugs
Not Eligible

You will not qualify if you...

  • Unfavorable intermediate-risk prostate cancer or higher risk disease
  • Chronic inflammatory bowel conditions such as IBD, Crohn's disease, sarcoidosis, or rheumatic disease
  • Chronic immunosuppression
  • Contraindications to hydrogel spacer placement
  • Contraindications to prostate MRI
  • Any prior prostate cancer treatment
  • Previous pelvic radiotherapy
  • Transurethral resection of the prostate (TURP) within the last 12 months
  • Presence of hip prosthesis
  • Prior use of therapeutic androgen deprivation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Davidoff Cancer Center, Rabin Medical Center

Petah Tikva, Israel, Israel, 49100

Actively Recruiting

Loading map...

Research Team

E

Elisha T Fredman, MD

CONTACT

A

Assaf Moore, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here