Prostate CancerHYPOPROSTNCT02300389
Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated
A study testing Hypofractionated IMRT boost radiotherapy and Conventional Fractionated IMRT boost radiotherapy in people with Prostate Cancer, run by The Greater Poland Cancer Centre at 3 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated IMRT boost radiotherapy and Conventional Fractionated IMRT boost radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 3 sitesPoland
- Study dates
- Dec 2011to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre
Olsztyn, Warmian-Masurian Voivodeship, 10-228
Greater Poland Cancer Centre
Poznan, Wielkopolska, 61-866
Lower-Silesian Oncology Centre
Wroclaw, Lower Silesian Voivodeship, 53-413
About this study
Official title: Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients
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.
Read the detailed description
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).
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated IMRT boost radiotherapy, Conventional Fractionated IMRT boost radiotherapy
- Keywords
- high risk prostate cancer radiotherapy hypofractionation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Conventional Fractionated IMRT boost radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical Progression Free Survival (bPFS)
Phoenix definition of biochemical failure
Measured: 5 years
Secondary outcomes (2)
Cause Specific Survival (CSS)
the period of time from randomization until death from prostate cancer
Measured: 5 years
Overall Survival (OS)
the period of time from randomization until death from any causes
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Greater Poland Cancer Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Milecki, PhD., MD, Principal investigator, Greater Poland Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300389
- Sponsor's protocol ID
- HYPOPROST
- Acronym
- HYPOPROST
- Status last verified
- Jan 2019
- First submitted
- 14 Nov 2014
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02300389
- Acronym / sponsor ID
- HYPOPROST / HYPOPROST
- Conditions
- Prostate Cancer
- Keywords
- high risk prostate cancer radiotherapy hypofractionation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- The Greater Poland Cancer CentreUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated IMRT boost radiotherapy | Experimental | Radiation: Hypofractionated IMRT boost radiotherapyAll 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 | Active comparator | Radiation: Conventional Fractionated IMRT boost radiotherapyAll 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated IMRT boost radiotherapyAll 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 radiotherapyAll 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 |
Primary outcome
biochemical Progression Free Survival (bPFS)
Time frame: 5 years
Phoenix definition of biochemical failure
2 secondary outcomes
Cause Specific Survival (CSS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Milecki, PhD., MD principal investigator
Greater Poland Cancer Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated IMRT boost radiotherapy and Conventional Fractionated IMRT boost radiotherapy in people with Prostate Cancer, run by The Greater Poland Cancer Centre at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical Progression Free Survival (bPFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.