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Recruiting

NCT Number: NCT02724670

Study of MR-based IGRT for Prostate Cancer

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

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Müller Arndt-Christian

Tübingen, 72076, Germany

Location status: Recruiting

Location contact

Arndt-Christian Müller

CONTACT

[email protected]

070712986143

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IGRT

Radiation

MR-based IGRT

Primary outcomes

  1. G2+gastrointestinal and genitourinary toxicity at 2 years

    Time frame: Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint

    Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years

Secondary outcomes

  1. Long-term GU-GI toxicity

    Time frame: 10 years after treatment

    Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Arndt-Christian Müller, Dr.

CONTACT

[email protected]

497071/2986142

Daniel Zips, Prof.

CONTACT

[email protected]

497071/2982165

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: M-basePro

Important dates

Study start
2016
Primary completion
2020
Study completion
2028
First posted
Mar 31, 2016
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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