Comparing two versus five sessions of radiation therapy for localized prostate cancer
Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual
This study tests whether giving radiation therapy for localized prostate cancer in just two sessions instead of the usual five can still be effective and make patients more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 562 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Rabin Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Petah Tikva, Israel) |
| Trial ID | NCT06027892 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two different schedules of stereotactic radiation therapy for patients with localized prostate cancer. It evaluates the effectiveness and safety of delivering the same total radiation dose in just two sessions versus the standard five sessions. The study utilizes advanced imaging and technology to minimize side effects to surrounding organs by employing a hydrogel spacer. The goal is to determine if fewer treatment sessions can maintain efficacy while improving patient comfort and resource utilization.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 and older with low- or favorable intermediate-risk prostate adenocarcinoma.
Not a fit: Patients with unfavorable intermediate-risk disease or those who have had prior prostate cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter treatment times and reduced side effects for patients with localized prostate cancer.
How similar studies have performed: Previous studies have shown promising results with similar approaches in stereotactic radiation therapy for prostate cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Petah Tikva, Israel
- Davidoff Cancer Center, Rabin Medical Center — Petah Tikva, Israel, Israel (Recruiting)
Study contacts
- Principal investigator: Elisha T Fredman, MD — Davidoff Cancer Center, Rabin Medical Center
- Study coordinator: Elisha T Fredman, MD
- Email: elishafre@clalit.org.il
- Phone: 9148744461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.