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Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated (HYPOPROST)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Hypofractionated IMRT boost radiotherapy

Conventional Fractionated IMRT boost radiotherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring high risk prostate cancer radiotherapy hypofractionation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Lower-Silesian Oncology Centre
Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre
Greater Poland Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypofractionated IMRT boost radiotherapy

Conventional Fractionated IMRT boost radiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

biochemical Progression Free Survival (bPFS)

Phoenix definition of biochemical failure

Secondary Outcome Measures

Cause Specific Survival (CSS)

the period of time from randomization until death from prostate cancer

Overall Survival (OS)

the period of time from randomization until death from any causes

Full Information

NCT ID

NCT02300389

First Posted

November 14, 2014

Last Updated

February 4, 2020

Sponsor

The Greater Poland Cancer Centre

1. Study Identification

Unique Protocol Identification Number

NCT02300389

Brief Title

Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

Acronym

HYPOPROST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Greater Poland Cancer Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival. Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors. Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors. Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors. Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

high risk prostate cancer radiotherapy hypofractionation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

288 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated IMRT boost radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Conventional Fractionated IMRT boost radiotherapy

Arm Type

Active Comparator

Arm Description

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 Type

Radiation

Intervention Name(s)

Hypofractionated IMRT boost radiotherapy

Intervention Description

Intervention Type

Radiation

Intervention Name(s)

Conventional Fractionated IMRT boost radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

biochemical Progression Free Survival (bPFS)

Description

Phoenix definition of biochemical failure

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Cause Specific Survival (CSS)

Description

the period of time from randomization until death from prostate cancer

Time Frame

5 years

Title

Overall Survival (OS)

Description

the period of time from randomization until death from any causes

Time Frame

5years

Other Pre-specified Outcome Measures:

Title

Toxicity of treatment

Description

for toxicity of treatment RTOG classification is applied

Time Frame

5 years

Title

Quality of Life (QOL)

Description

for Quality of Life (QOL) the EORTC C30 and module PR25 is used.

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piotr Milecki, PhD., MD

Organizational Affiliation

Greater Poland Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lower-Silesian Oncology Centre

City

Wroclaw

State/Province

Lower-Silesian

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre

City

Olsztyn

State/Province

Warmia-mazury

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Greater Poland Cancer Centre

City

Poznan

State/Province

Wielkopolska

ZIP/Postal Code

61-866

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

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Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

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