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HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer. (PROMOBRA)

Primary Purpose

Adenocarcinoma of Prostate

Status
Unknown status
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
LDR Brachytherapy
HDR Brachytherapy
Sponsored by
National Institute of Oncology, Hungary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of Prostate focused on measuring Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) status <=1
  • 40-75 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

Exclusion Criteria:

  • <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

Sites / Locations

  • Peter AgostonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LDRPBT

HDRPBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

quality of life
Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).
quality of life
Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire
Biochemical relapse free survival (bRFS)
Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)
Locoregional tumor free survival
Censoring an event when either local or regional relapse occurs
Disease specific survival (DSS)
Censoring an event when patient dies due to prostate cancer

Full Information

First Posted
September 30, 2014
Last Updated
October 2, 2014
Sponsor
National Institute of Oncology, Hungary
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1. Study Identification

Unique Protocol Identification Number
NCT02258087
Brief Title
HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.
Acronym
PROMOBRA
Official Title
Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Oncology, Hungary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer. There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy. In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy. Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group. Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Prostate
Keywords
Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDRPBT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HDRPBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
LDR Brachytherapy
Other Intervention Name(s)
Seed brachytherapy, Permanent implantation prostate brachytherapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
HDR Brachytherapy
Other Intervention Name(s)
temporary implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute side effects
Description
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
Time Frame
6 months
Title
Chronic side effects
Description
Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale
Time Frame
from 6 months to five year
Secondary Outcome Measure Information:
Title
quality of life
Description
Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).
Time Frame
5 years
Title
quality of life
Description
Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire
Time Frame
5 years
Title
Biochemical relapse free survival (bRFS)
Description
Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)
Time Frame
5 years
Title
Locoregional tumor free survival
Description
Censoring an event when either local or regional relapse occurs
Time Frame
5 years
Title
Disease specific survival (DSS)
Description
Censoring an event when patient dies due to prostate cancer
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) status <=1 40-75 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 Exclusion Criteria: <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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Agoston, MD PHD
Phone
+361 2248600
Ext
3186
Email
agoston.p@oncol.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Csaba Polgar, MD, PHD
Email
polgar@oncol.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Agoston, MD, PHD
Organizational Affiliation
NIO, Hungary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Agoston
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Agoston, MD, PHD
Phone
+3612248600
Ext
3186
Email
agoston.p@oncol.hu
First Name & Middle Initial & Last Name & Degree
Csaba Polgar, MD PHD
Email
polgar@oncol.hu

12. IPD Sharing Statement

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HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.

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