NCT02895854

Brief Summary

The aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.

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
44

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2013

Longer than P75 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 8, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 years until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

6 years

First QC Date

September 9, 2013

Last Update Submit

February 17, 2021

Conditions

Prostate Cancer

Keywords

Low risk prostate cancerIntermediate risk prostate cancerLow dose-rate brachytherapyHypofractionatedRobotic external beam radiationQuality of life

Outcome Measures

Primary Outcomes (1)

  • Differences in acute adverse effects

    questionnaires

    6 months

Secondary Outcomes (3)

  • Time to PSA response

    6 months

  • Time to PSA nadir

    2 years

  • Biological progression free survival (bPFS)

    3 years

Other Outcomes (1)

  • Cost utility

    3 years

Study Arms (2)

LDR-brachytherapy with I125 seeds

ACTIVE COMPARATOR

Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.

Radiation: LDR-brachytherapy with I125 seeds

Hypofractionated RT 5 x 7,25 Gy

ACTIVE COMPARATOR

Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.

Radiation: Hypofractionated RT 5 x 7,25 Gy

Interventions

Hypofractionated RT 5 x 7,25 GyRADIATION
Hypofractionated RT 5 x 7,25 Gy
LDR-brachytherapy with I125 seedsRADIATION
LDR-brachytherapy with I125 seeds

Eligibility Criteria

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

You may qualify if:

  • biopsy proven adenocarcinoma of the prostate
  • Gleason score ≤ 3+4
  • clinical and radiological TNM T1c-2c, N0-X, M0-X, PSA ≤ 20ng/ml and WHO 0-2
  • low or intermediate risk prostate cancer according to National Comprehensive Cancer Network (NCCN) classification

You may not qualify if:

  • clinical TNM ≥ T3
  • Gleason score ≥ 4+3
  • high risk prostate cancer according to NCCN classification
  • history of cancer (other than PC) during the past 5 years (excluding basalioma and squamocellular carcinoma of the skin)
  • previous pelvic radiotherapy
  • previous active treatments of prostate cancer (active surveillance allowed)
  • bilateral hip prothesis or other implant impedes pelvic TT or MRI imaging
  • clopidogrel medication
  • poor co-operation
  • life expectancy \< 5 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70210, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kristiina Vuolukka, MD

    Cancer Center, KUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2016

Study Start

January 8, 2013

Primary Completion

December 20, 2018

Study Completion

December 31, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

FI(1)