Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

Prostate Cancer Clinical Trial

— HYPOPROST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300389
• Other study ID #: HYPOPROST
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: The Greater Poland Cancer Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre	Olsztyn	Warmia-mazury
Poland	Greater Poland Cancer Centre	Poznan	Wielkopolska
Poland	Lower-Silesian Oncology Centre	Wroclaw	Lower-Silesian

Sponsors (1)

Lead Sponsor	Collaborator
The Greater Poland Cancer Centre

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity of treatment	for toxicity of treatment RTOG classification is applied	5 years
Other	Quality of Life (QOL)	for Quality of Life (QOL) the EORTC C30 and module PR25 is used.	5 years
Primary	biochemical Progression Free Survival (bPFS)	Phoenix definition of biochemical failure	5 years
Secondary	Cause Specific Survival (CSS)	the period of time from randomization until death from prostate cancer	5 years
Secondary	Overall Survival (OS)	the period of time from randomization until death from any causes	5years