NCT02724670

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
28mo left

Started Mar 2016

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Mar 2016Sep 2028

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Expected
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

4.3 years

First QC Date

March 10, 2016

Last Update Submit

September 23, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Long-term GU-GI toxicity

    10 years after treatment

Study Arms (1)

Radiation

OTHER

IGRT 5x 2Gy/week, total dose: 78 Gy

Radiation: IGRT

Interventions

IGRTRADIATION

MR-based IGRT

Radiation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven prostate cancer
  • indication for curative treatment
  • ECOG performance scale 0-2
  • Informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Müller Arndt-Christian

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Arndt-Christian Müller, Dr.

    Department of Radiation Oncology, University of Tübingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arndt-Christian Müller, Dr.

CONTACT

497071/2986142Arndt-Christian.Mueller@med.uni-tuebingen.de

Daniel Zips, Prof.

CONTACT

497071/2982165Daniel.Zips@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 31, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2020

Study Completion (Estimated)

September 1, 2028

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

DE(1)