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NCT Number: NCT02300389

Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lower-Silesian Oncology Centre, Wroclaw, Lower Silesian Voivodeship, Poland

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypofractionated IMRT boost radiotherapy

Radiation

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.

Conventional Fractionated IMRT boost radiotherapy

Radiation

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 outcomes

  1. biochemical Progression Free Survival (bPFS)

    Time frame: 5 years

    Phoenix definition of biochemical failure

Secondary outcomes

  1. Cause Specific Survival (CSS)

    Time frame: 5 years

    the period of time from randomization until death from prostate cancer

  2. Overall Survival (OS)

    Time frame: 5years

    the period of time from randomization until death from any causes

Other outcomes

  1. Toxicity of treatment

    Time frame: 5 years

    for toxicity of treatment RTOG classification is applied

  2. Quality of Life (QOL)

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

The Greater Poland Cancer Centre

Other

Registry information

Official study title

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

Acronym: HYPOPROST

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2014
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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