Single-dose radiation therapy for prostate cancer
ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
This study is testing if a single high-dose radiation treatment can safely and effectively help men with localized prostate cancer while causing less harm to healthy tissue.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT03294889 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the safety and effectiveness of a single high-dose stereotactic body radiation therapy (SBRT) of 19 Gy in patients with localized prostate cancer. The study will utilize advanced image-guided radiation techniques to potentially enhance tumor control while minimizing damage to surrounding healthy tissues. By exploring ultra-hypofractionation, the trial seeks to determine if fewer treatment sessions can achieve similar or better outcomes compared to traditional radiation schedules. The trial is designed as a phase I/II study to gather preliminary data before a larger phase III trial.
Who should consider this trial
Good fit: Ideal candidates include men with localized prostate cancer, specifically those with a Gleason score of 3+3 or 3+4 and a PSA level of 15 ng/ml or lower.
Not a fit: Patients with advanced prostate cancer (clinical stage cT3 or higher) or those with metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less time-consuming treatment option for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy, suggesting that this approach may be effective, though this specific single-dose method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures * Histologically confirmed adenocarcinoma of the prostate without small cell features * Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009 * MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c * Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2) * PSA ≤15 ng/ml * WHO performance status 0-1 * International Prostate Symptom Score ≤ 10 (alpha blockers allowed) * MRI-based volume estimation of prostate gland ≤ 70 cc * Patient agrees not to father a child during trial treatment and during 6 months thereafter Exclusion Criteria: * Tumor clinical stage cT3a-3b or T4 * Evidence of T3a, T3b or T4 disease as assessed by MRI * Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies. * Significant tumor on the transitional zone as assessed by MRI * Gleason at biopsy ≥ 4+3 * Androgen deprivation therapy or products known to affect PSA levels * Impossibility to implant Calypso beacons * History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer * Prior pelvic radiotherapy * Previous surgery for prostate cancer * Previous transurethral resection of the prostate (TURP) (\< 12 weeks before registration) * Hip prosthesis * Severe or active co-morbidity likely to impact on the advisability of SBRT * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
Where this trial is running
Geneva
- University Hospital of Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Thomas Zilli, MD — University Hospital, Geneva
- Study coordinator: Thomas Zilli, MD
- Email: Thomas.Zilli@hcuge.ch
- Phone: +41 79 55 32 563
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.