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

Sponsor
National Institute of Oncology, Hungary (Other)
Overall Status
Unknown status
CT.gov ID
NCT02258087
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
60
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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 Names:
  • temporary implant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute side effects [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 [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 [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 [5 years]

      Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire

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

      Censoring an event when either local or regional relapse occurs

    5. Disease specific survival (DSS) [5 years]

      Censoring an event when patient dies due to prostate cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Peter Agoston Budapest Hungary 1122

    Sponsors and Collaborators

    • National Institute of Oncology, Hungary

    Investigators

    • Principal Investigator: Peter Agoston, MD, PHD, NIO, Hungary

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Agoston, MD, PhD, National Institute of Oncology, Hungary
    ClinicalTrials.gov Identifier:
    NCT02258087
    Other Study ID Numbers:
    • PROMOBRA-2013
    First Posted:
    Oct 7, 2014
    Last Update Posted:
    Oct 7, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Peter Agoston, MD, PhD, National Institute of Oncology, Hungary
    Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Oct 7, 2014