LDR Brachytherapy Versus SBRT for Low and Intermediate Ri... | NCT02895854

Studies
LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients

NCT02895854

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Feb 18, 2021Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

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

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2013Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2021

Last Update Posted Date

Feb 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Prostate cancer (PC) is the most common solid malignancy among the men in the Western world. The classification to low, intermediate and high risk groups is determined by the PSA, Gleason score and clinical TNM status at the moment of diagnosis. There are several treatment options available for patients with low and intermediate risk PC and generally their prognosis is good. The men live long after their radical treatments and they have to live with the possible adverse effects caused by the treatment.

In this prospective, randomised clinical trial we are comparing two radiotherapy modalities to find out if there are differences in the acute and late adverse effects among men treated either by low dose-rate (LDR) brachytherapy or hypofractionated external radiotherapy. Also the PSA-responses and cost utilities will be analysed. The number of patients recruited for the study is 60 and the patients will be randomised 1:1 to each treatment arm.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hypofractionated RT 5 x 7,25 Gy	Radiation		Hypofractionated RT 5 x 7,25 Gy
LDR-brachytherapy with I125 seeds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in acute adverse effects	questionnaires	6 months

Secondary Outcomes

Measure	Description	Time Frame
Time to PSA response		6 months
Time to PSA nadir		2 years
Biological progression free survival (bPFS)

Other Outcomes

Measure	Description	Time Frame
Cost utility		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristiina Vuolukka, MD	Cancer Center, KUH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio		70210	Finland

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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