Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated (HYPOPROST)

February 4, 2020 updated by: The Greater Poland Cancer Centre

Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lower-Silesian
      • Wroclaw, Lower-Silesian, Poland, 53-413
        • Lower-Silesian Oncology Centre
    • Warmia-mazury
      • Olsztyn, Warmia-mazury, Poland, 10-228
        • Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre
    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 61-866
        • Greater Poland Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical Progression Free Survival (bPFS)
Time Frame: 5 years
Phoenix definition of biochemical failure
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cause Specific Survival (CSS)
Time Frame: 5 years
the period of time from randomization until death from prostate cancer
5 years
Overall Survival (OS)
Time Frame: 5years
the period of time from randomization until death from any causes
5years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity of treatment
Time Frame: 5 years
for toxicity of treatment RTOG classification is applied
5 years
Quality of Life (QOL)
Time Frame: 5 years
for Quality of Life (QOL) the EORTC C30 and module PR25 is used.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Greater Poland Cancer Centre

Investigators

  • Principal Investigator: Piotr Milecki, PhD., MD, Greater Poland Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPOPROST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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