Adaptive MR-guided SBRT for Localized Prostate Cancer

NCT04571762 | Not Yet Recruiting

• 1 other identifier: iAdapt-Prostate
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate a technical feasibility of MR-guided SBRT fraction dose adaptation for low-risk, intermediate-risk and low-volume metastatic prostate cancer. .

Conditions

Prostate Cancer

Keywords

SBRT; MR-Linac; Adaptive radiotherapy; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of online MR-guided SBRT: Number of fractions

  Number of fractions when a new online plan on the new patient geometry was successfully generated and applied according to the dosimetric protocol requirements

  At the treatment end (treatment duration 2 weeks)

Secondary Outcomes (5)

• Rates of adverse events

  weekly during treatment and up to 3 months after the treatment end

• Quantifying intrafraction motion of the prostate (in mm) and organs-at-risk (in mm)

  During each treatment session (treatment duration of 2 weeks)

• Quantifying interfraction motion of the prostate (in mm) and organs-at-risk (in mm)

  Before each treatment session (treatment duration of 2 weeks)

• Quality of the adapted treatment plan vs. the initial treatment plan

  At the treatment end (treatment duration 2 weeks)

• Duration of an online adaptive procedure

  Before each treatment session (treatment duration 2 weeks)

Study Arms (1)

Single arm

EXPERIMENTAL

Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

SBRT (a fraction dose adapted to the OAR geometry-of-the-day, 5 fractions) performed on the MR-Linac

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures;
• Males;
• Histologically confirmed adenocarcinoma of the prostate;
• Low (Grade group 1 \[Gleason score ≤6\], clinical stage T1-2a N0 M0, and PSA \< 10 ng/ml) and intermediate (Grade group 2-3 \[Gleason score 7\], clinical stage T2b-2c N0 M0, PSA 10-20 ng/ml) risk prostate cancer with indications for SBRT with curative intent;
• Newly diagnosed low-volume metastatic prostate cancer with indications for SBRT, in whom metastatic disease was confirmed on a bone scintigraphic scan and soft-tissue imaging done within 3 months of starting androgen deprivation therapy (ADT);
• IPSS \<15;
• Age: ≥ 18 years old;
• Karnofsky performance status ≥70;
• Patients able to tolerate long (approximately 60 minutes) treatment time;
• Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.

You may not qualify if:

• Previous radical treatment for prostate cancer - either radiation therapy (external or brachytherapy), surgery, TUR-P, cryosurgery, or HIFU;
• Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia;
• Lack of safe contraception;
• Known or suspected non-compliance, drug or alcohol abuse;
• Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sponsors & Collaborators

• University of Zurich: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nocolaus Andratschke, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nocolaus Andratschke, MD

CONTACT

+41 44 255 31 50; nicolaus.andratschke@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: October 1, 2020
• Study Start: September 30, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05