NCT02258087

Brief Summary

Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.

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
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_2

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

September 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

September 30, 2014

Last Update Submit

October 2, 2014

Conditions

Adenocarcinoma of Prostate

Keywords

Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy

Outcome Measures

Primary Outcomes (2)

  • Acute side effects

    Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale

    6 months

  • Chronic side effects

    Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale

    from 6 months to five year

Secondary Outcomes (5)

  • quality of life

    5 years

  • quality of life

    5 years

  • Biochemical relapse free survival (bRFS)

    5 years

  • Locoregional tumor free survival

    5 years

  • Disease specific survival (DSS)

    5 years

Study Arms (2)

LDRPBT

ACTIVE COMPARATOR

Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.

Radiation: LDR Brachytherapy

HDRPBT

EXPERIMENTAL

Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.

Radiation: HDR Brachytherapy

Interventions

LDR BrachytherapyRADIATION

In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.

Also known as: Seed brachytherapy, Permanent implantation prostate brachytherapy
LDRPBT
HDR BrachytherapyRADIATION

In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.

Also known as: temporary implant
HDRPBT

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) status \<=1
  • years old
  • expected life expectancy\>10 years
  • low risk prostate cancer (Prostate specific antigen (PSA)\<=10ng/ml, gleason score \<7, T status\<=2a), less than 50 % positive biopsy cores
  • selected intermediate prostate cancer (PSA)=10-\<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
  • International prostate symptom score (IPSS) \<=15
  • Prostate volume\<=50cm3
  • no pubic interference
  • no prior prostate operation, except biopsy
  • no prior radiation to pelvis
  • patient signed the informed consent

You may not qualify if:

  • \<40 years or \>75 years old
  • PSA\>15 ng/ml gleason score 4+3 , score 8-10
  • ECOG\>=2
  • T3-4
  • percent core positivity \>50 %
  • TUR operation within six months prior to the brachytherapy prostate volume\<10 cm3 or \>50 cm3 IPSS \>15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter Agoston

Budapest, 1122, Hungary

RECRUITING

MeSH Terms

Conditions

NeoplasmsBarakat syndrome

Study Officials

  • Peter Agoston, MD, PHD

    NIO, Hungary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Agoston, MD PHD

CONTACT

+361 2248600agoston.p@oncol.hu

Csaba Polgar, MD, PHD

CONTACT

polgar@oncol.hu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 7, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2019

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

HU(1)