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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRabin Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients ≥18 years

Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma

T1-T2c

Prostate specific antigen < 20

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Two-fraction stereotactic radiotherapy

    Radiation

    Definitive prostate radiotherapy will be delivered to a dose biologically comparable to 40 Gy in 5 treatments, but in only 2 treatments

  • Five-fraction stereotactic radiotherapy

    Radiation

    Definitive prostate radiotherapy will be delivered to a standard stereotactic dose of 40 Gy in 5 treatments

Treatment groups

562 Participants
are divided into 2 treatment groups
Group A: Two-fraction stereotactic radiotherapyExperimental treatment 1 intervention
Group B: Five-fraction stereotactic radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Biochemical Progression Free Survival

Phoenix definition

Time frame
five-year

Secondary outcomes

1

Freedom From Progression

biochemical failure, clinical failure, death from any cause

Time frame
five-year
2

Distant metastasis free survival

Survival without development of distant metastatic disease

Time frame
five-year
3

Prostate cancer specific survival

Survival with cause of death or censoring without residual or recurrent prostate cancer

Time frame
five-year
4

Time to prostate specific antigen nadir (< 0.2) - Longitudinal response

Biochemical prostate specific antigen response over time

Time frame
five-year

Other outcomes

Sponsors and contacts

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