NCT06027892Recruiting
Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer
Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 562 (estimated)
- First submitted
- 31 Aug 2023
- Start date
- 29 Dec 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- Rabin Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT06027892
What you commit to
- Study type: Interventional
- Planned participants: 562
- From 29 Dec 2022 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion:
- Male patients ≥18 years
- Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma
- T1-T2c
- Prostate specific antigen \< 20
- Gleason 6 or 7 (3+4)
- Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease
- Prostate gland \< 60 cc (can include following cytoreductive androgen deprivation)
- International Prostate Symptom Score \< 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)
- Exclusion:
- Unfavorable intermediate-risk disease and above
- Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)
- Chronic immunosuppression
- Contraindications to hydrogel spacer placement
- Contraindications to a prostate MRI
- Any prior prostate cancer treatment
- Prior pelvic radiotherapy
- Previous transurethral resection of the prostate (TURP) within 12 months
- Hip prosthesis
- Prior use of therapeutic androgen deprivation therapy
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Davidoff Cancer Center, Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.