Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

NCT ID: NCT02300389

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2019-12-31

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:

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hypofractionated IMRT boost radiotherapy

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Conventional Fractionated IMRT boost radiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Greater Poland Cancer Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Milecki, PhD., MD

Role: PRINCIPAL_INVESTIGATOR

Greater Poland Cancer Centre

Locations

Lower-Silesian Oncology Centre

Wroclaw, Lower Silesian Voivodeship, Poland

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

Olsztyn, Warmian-Masurian Voivodeship, Poland

Greater Poland Cancer Centre

Poznan, Wielkopolska, Poland

Countries

Poland

Other Identifiers

HYPOPROST

Identifier Type: -

Identifier Source: org_study_id