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Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated (HYPOPROST)

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ClinicalTrials.gov Identifier: NCT02300389
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
The Greater Poland Cancer Centre

Tracking Information
First Submitted Date  ICMJE November 14, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date February 6, 2020
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
biochemical Progression Free Survival (bPFS) [ Time Frame: 5 years ]
Phoenix definition of biochemical failure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
  • Cause Specific Survival (CSS) [ Time Frame: 5 years ]
    the period of time from randomization until death from prostate cancer
  • Overall Survival (OS) [ Time Frame: 5years ]
    the period of time from randomization until death from any causes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 24, 2014)
  • Toxicity of treatment [ Time Frame: 5 years ]
    for toxicity of treatment RTOG classification is applied
  • Quality of Life (QOL) [ Time Frame: 5 years ]
    for Quality of Life (QOL) the EORTC C30 and module PR25 is used.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated
Official Title  ICMJE Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients
Brief Summary The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients combined with Androgen Deprivation Therapy.
Detailed Description

Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows:

  1. Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival.
  2. Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors.
  3. Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
  4. Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors.
  5. Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: Hypofractionated IMRT boost radiotherapy
    All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with hypofractionated dose of 7.5 Gy in two fractions (II phase) to the total dose of 61 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.
  • Radiation: Conventional Fractionated IMRT boost radiotherapy
    All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with conventional fractionated dose of 2 Gy in 15 fractions (II phase) to the total dose of 76 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.
Study Arms  ICMJE
  • Experimental: Hypofractionated IMRT boost radiotherapy
    All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with hypofractionated dose of 7.5 Gy in two fractions (II phase) to the total dose of 61 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.
    Intervention: Radiation: Hypofractionated IMRT boost radiotherapy
  • Active Comparator: Conventional Fractionated IMRT boost radiotherapy
    All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with conventional fractionated dose of 2 Gy in 15 fractions (II phase) to the total dose of 76 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.
    Intervention: Radiation: Conventional Fractionated IMRT boost radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2020)
288
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2014)
465
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • men from 40 to 75 years old with confirmed prostate adenocarcinoma, prostate biopsy will be performed <180 days before the date of randomization,
  • completed assessment of tumor differentiation according to Gleason grading allows to perform stratification; Gleason score ≤ 7 versus Gleason score> 8,
  • general condition according to the classification of the Eastern Cooperative Oncology Group (ECOG) 0 - 1), (Appendix 1),
  • Androgen Deprivation Therapy: prior Radiotherapy (RT) (minimum 3 months before the start of RT), concurrently with RT and after RT during follow-up (24 months) ,
  • high risk of Prostate Cancer progression defined as presence of at least one of the following factors: cT3, Gleason> 7, PSA> 20 ng / ml or presence of at least two of cT2c, Gleason 7, PSA in the range of 10.1 ng / ml to 19.9 ng / ml, cT defined by AJCC staging 7 edition, (Appendix 2),
  • PSA identified at least 10 days after the biopsy or before, and patients receiving fiansteryd 30 days after the cessation of therapy,
  • no regional and distant metastases confirmed by bone scintigraphy, chest radiograph, computed tomography/magnetic resonance imaging of the pelvis,
  • signing an informed consent to participate in a medical experiment (radiotherapy + biological material samples) (Annex 3),
  • morphological and biochemical parameters within normal limits.

Exclusion Criteria:

  • the presence of active cancer except skin cancer preceding period of 5 years prior to randomization,
  • Early surgery (radical prostatectomy) or pelvic RT,
  • earlier hormonal therapy than is advocated in this study,
  • co-morbidities that may significantly affect the expectancy life of the patients
  • do not meet the criteria for inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300389
Other Study ID Numbers  ICMJE HYPOPROST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Greater Poland Cancer Centre
Study Sponsor  ICMJE The Greater Poland Cancer Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Piotr Milecki, PhD., MD Greater Poland Cancer Centre
PRS Account The Greater Poland Cancer Centre
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP