Study of MR-based IGRT for Prostate Cancer

Prostate Cancer Clinical Trial

— M-basePro  

Official title:

Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02724670
• Other study ID #: M-base Pro 1.0
• Status: Recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 2028

Study information

• Verified date: September 2019
• Source: University Hospital Tuebingen
• Contact: Arndt-Christian Müller, Dr.
• Phone: 497071/2986142
• Email: Arndt-Christian.Mueller[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.

Description:

Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer.

Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: September 2028
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically proven prostate cancer

• indication for curative treatment

• ECOG performance scale 0-2

• Informed consent

Exclusion Criteria:

• contraindications for curative treatment

• age<18year

• previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound)

• serious comorbidity leading to inability for IGRT (image-guided radiotherapy)

• contraindications for MRI (Magnetic Resonance Imaging)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• IGRT
MR-based IGRT

Locations

Country	Name	City	State
Germany	Müller Arndt-Christian	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	G2+gastrointestinal and genitourinary toxicity at 2 years	Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years	Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint
Secondary	Long-term GU-GI toxicity	Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years	10 years after treatment