NCT02300389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2020

Status Verified

January 1, 2019

Enrollment Period

8 years

First QC Date

November 14, 2014

Last Update Submit

February 4, 2020

Conditions

Prostate Cancer

Keywords

high risk prostate cancer radiotherapy hypofractionation

Outcome Measures

Primary Outcomes (1)

  • biochemical Progression Free Survival (bPFS)

    Phoenix definition of biochemical failure

    5 years

Secondary Outcomes (2)

  • Cause Specific Survival (CSS)

    5 years

  • Overall Survival (OS)

    5years

Other Outcomes (2)

  • Toxicity of treatment

    5 years

  • Quality of Life (QOL)

    5 years

Study Arms (2)

Hypofractionated IMRT boost radiotherapy

EXPERIMENTAL

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

Conventional Fractionated IMRT boost radiotherapy

ACTIVE COMPARATOR

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

Interventions

Hypofractionated IMRT boost radiotherapyRADIATION

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.

Hypofractionated IMRT boost radiotherapy
Conventional Fractionated IMRT boost radiotherapyRADIATION

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.

Conventional Fractionated IMRT boost radiotherapy

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lower-Silesian Oncology Centre

Wroclaw, Lower Silesian Voivodeship, 53-413, Poland

Location

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

Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

Location

Greater Poland Cancer Centre

Poznan, Wielkopolska, 61-866, Poland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Piotr Milecki, PhD., MD

    Greater Poland Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 25, 2014

Study Start

December 1, 2011

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(3)