Single-dose radiation therapy for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.