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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Greater Poland Cancer Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings