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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02258087
Recruitment Status : Unknown
Verified October 2014 by Peter Agoston, National Institute of Oncology, Hungary.
Recruitment status was:  Recruiting
First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Peter Agoston, National Institute of Oncology, Hungary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Prostate Radiation: LDR Brachytherapy Radiation: HDR Brachytherapy Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LDRPBT
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
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.
Other Names:
  • Seed brachytherapy
  • Permanent implantation prostate brachytherapy
Experimental: HDRPBT
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
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.
Other Name: temporary implant


Outcome Measures
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Primary Outcome Measures :
  1. Acute side effects [ Time Frame: 6 months ]
    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

  2. Chronic side effects [ Time Frame: from 6 months to five year ]
    Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale


Secondary Outcome Measures :
  1. quality of life [ Time Frame: 5 years ]
    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).

  2. quality of life [ Time Frame: 5 years ]
    Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire

  3. Biochemical relapse free survival (bRFS) [ Time Frame: 5 years ]
    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)

  4. Locoregional tumor free survival [ Time Frame: 5 years ]
    Censoring an event when either local or regional relapse occurs

  5. Disease specific survival (DSS) [ Time Frame: 5 years ]
    Censoring an event when patient dies due to prostate cancer


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258087


Contacts
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Contact: Peter Agoston, MD PHD +361 2248600 ext 3186 agoston.p@oncol.hu
Contact: Csaba Polgar, MD, PHD polgar@oncol.hu

Locations
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Hungary
Peter Agoston Recruiting
Budapest, Hungary, 1122
Contact: Peter Agoston, MD, PHD    +3612248600 ext 3186    agoston.p@oncol.hu   
Contact: Csaba Polgar, MD PHD       polgar@oncol.hu   
Sponsors and Collaborators
National Institute of Oncology, Hungary
Investigators
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Principal Investigator: Peter Agoston, MD, PHD NIO, Hungary
More Information
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Responsible Party: Peter Agoston, MD, PhD, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT02258087    
Other Study ID Numbers: PROMOBRA-2013
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Peter Agoston, National Institute of Oncology, Hungary:
Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type