NCT03880851

Brief Summary

Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 23, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

5 years

First QC Date

February 11, 2019

Last Update Submit

March 18, 2019

Conditions

Prostate Cancer

Keywords

hypofractionationMR-based IGRTMbase HyPro

Outcome Measures

Primary Outcomes (1)

  • Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2

    Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%

    2 years

Secondary Outcomes (10)

  • Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT

    6 months

  • Rate of participants achieving local control

    2, 5, 10 years

  • Rate of participants achieving regional control

    2, 5, 10 years

  • Rate of participants achieving Distant-metastasis-free survival "DMFS"

    2, 5, 10 years

  • Number of Participants with biochemical no evidence of disease "bNED"

    2, 5, 10 years

  • +5 more secondary outcomes

Study Arms (1)

Hypofractionated image-guided radiotherapy

OTHER

Hypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed. Weekly MRI are used to estimate volume/deformation changes of OAR and target volume. Intervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy.

Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes

Interventions

Plan adaptation of Radiation Treatment in case of anatomical changesRADIATION

Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.

Hypofractionated image-guided radiotherapy

Eligibility Criteria

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

You may qualify if:

  • biopsy-proven prostate cancer with indication for RT
  • cT1b-cT3a cN0 cM0
  • ECOG Performance score 0-2
  • IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
  • age\>18 years
  • Informed consent

You may not qualify if:

  • contraindication against curative RT
  • age\<18 years
  • previous pelvic radiotherapy or planned pelvic radiotherapy
  • comorbidities interfering with image-guided radiotherapy
  • contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)
  • prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate

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

Central Study Contacts

Silke Theden

CONTACT

+49707183420silke.theden@med.uni-tuebingen.de

Arndt-Christian Müller

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of the Department of Radiation Oncology

Study Record Dates

First Submitted

February 11, 2019

First Posted

March 19, 2019

Study Start

January 23, 2019

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

DE(1)