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Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated (HYPOPROST)

This study is currently recruiting participants.
Verified January 2017 by The Greater Poland Cancer Centre
Sponsor:
ClinicalTrials.gov Identifier:
NCT02300389
First Posted: November 25, 2014
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Greater Poland Cancer Centre
  Purpose
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.

Condition Intervention
Prostate Cancer Radiation: Hypofractionated IMRT boost radiotherapy Radiation: Conventional Fractionated IMRT boost radiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by The Greater Poland Cancer Centre:

Primary Outcome Measures:
  • biochemical Progression Free Survival (bPFS) [ Time Frame: 5 years ]
    Phoenix definition of biochemical failure


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 465
Study Start Date: December 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300389


Contacts
Contact: Piotr Milecki, PhD., MD +4861885878 piotr.milecki@wco.pl

Locations
Poland
Lower-Silesian Oncology Centre Recruiting
Wroclaw, Lower-Silesian, Poland, 53-413
Contact: Adam Maciejczyk, PhD., MD    +48 71 36 89 501    maciejczyk.a@dco.com.pl   
Contact: Marzena Janiszewska, PhD.    +48 71 36 89 588    janiszewska.m@dco.com.pl   
Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre Recruiting
Olsztyn, Warmia-mazury, Poland, 10-228
Contact: Monika Rucińska, PhD.    +48 89 53 98 310    mrucinska@poczta.onet.pl   
Contact: Agnieszka Ounap-Karnak Ounap-Karnak, MD    +48 89 53 98 921    agnieszkaounap@wp.pl   
Greater Poland Cancer Centre Recruiting
Poznan, Wielkopolska, Poland, 61-866
Contact: Piotr Milecki, MD PhD    +48 61 885 08 78    piotr.milecki@wco.pl   
Contact: Joanna Markiewicz, MA    +48 61 885 08 78    joanna.markiewicz@wco.pl   
Principal Investigator: Piotr Milecki, MD PhD         
Sponsors and Collaborators
The Greater Poland Cancer Centre
Investigators
Principal Investigator: Piotr Milecki, PhD., MD Greater Poland Cancer Centre
  More Information

Responsible Party: The Greater Poland Cancer Centre
ClinicalTrials.gov Identifier: NCT02300389     History of Changes
Other Study ID Numbers: HYPOPROST
First Submitted: November 14, 2014
First Posted: November 25, 2014
Last Update Posted: April 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Greater Poland Cancer Centre:
high risk prostate cancer radiotherapy hypofractionation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs