Adenocarcinoma of ProstatePhase 2/3PROMOBRANCT02258087
HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.
A Phase 2/3 study testing LDR Brachytherapy and HDR Brachytherapy in people with Adenocarcinoma of Prostate, run by National Institute of Oncology, Hungary at 1 site in Hungary.
Trial summary
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Adenocarcinoma of Prostate
- What is being tested?
- LDR Brachytherapy and HDR Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2014to Sep 2019
- Phase
- Phase 2/3
- 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
- Eastern Cooperative Oncology Group (ECOG) status <=1
- 40-75 years old
- expected life expectancy>10 years
- low risk prostate cancer (Prostate specific antigen (PSA)<=10ng/ml, gleason score <7, T status<=2a), less than 50 % positive biopsy cores
- selected intermediate prostate cancer (PSA)=10-<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
- International prostate symptom score (IPSS) <=15
Show all 11Show fewer
- Prostate volume<=50cm3
- no pubic interference
- no prior prostate operation, except biopsy
- no prior radiation to pelvis
- patient signed the informed consent
Who cannot join
- <40 years or >75 years old
- PSA>15 ng/ml gleason score 4+3 , score 8-10
- ECOG>=2
- T3-4
- percent core positivity >50 %
- TUR operation within six months prior to the brachytherapy prostate volume<10 cm3 or >50 cm3 IPSS >15
Trial locations and contacts
1 site in 1 country.
Csaba Polgar, MD, PHD contact
Hungary1 site, 1 recruiting
- Recruiting
Peter Agoston
Budapest, 1122
Peter Agoston, MD, PHD, +3612248600 ext. 3186, agoston.p@oncol.hu
Csaba Polgar, MD PHD, polgar@oncol.hu
About this study
Official title: Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.
Read the detailed description
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer.
There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.
In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.
Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.
Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.
- Conditions
- Adenocarcinoma of Prostate
- Being tested
- LDR Brachytherapy, HDR Brachytherapy
- Keywords
- Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy
- Medical subject headings
- Neoplasms, Barakat syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDR BrachytherapyRadiation
Also called Seed brachytherapy, Permanent implantation prostate brachytherapy
In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.
HDR BrachytherapyRadiation
Also called temporary implant
In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.
| Study group | Role | What they receive |
|---|---|---|
| LDRPBT | Active comparator | Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied. Receives: Radiation: LDR Brachytherapy |
| HDRPBT | Experimental | Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied. Receives: Radiation: HDR Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute side effects
Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale
Measured: 6 months
Chronic side effects
Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale
Measured: from 6 months to five year
Secondary outcomes (5)
quality of life
Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).
Measured: 5 years
quality of life
Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire
Measured: 5 years
Biochemical relapse free survival (bRFS)
Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)
Measured: 5 years
Locoregional tumor free survival
Censoring an event when either local or regional relapse occurs
Measured: 5 years
Disease specific survival (DSS)
Censoring an event when patient dies due to prostate cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of ProstateStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Oncology, Hungary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Agoston, National Institute of Oncology, Hungary
- Investigators
- Peter Agoston, MD, PHD, Principal investigator, NIO, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258087
- Sponsor's protocol ID
- PROMOBRA-2013
- Acronym
- PROMOBRA
- Status last verified
- Oct 2014
- First submitted
- 30 Sep 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
- ClinicalTrials.gov ID
- NCT02258087
- Acronym / sponsor ID
- PROMOBRA / PROMOBRA-2013
- Conditions
- Adenocarcinoma of Prostate
- Keywords
- Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Oncology, HungaryUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 7 Oct 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.
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.
Detailed description
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer.
There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.
In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.
Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.
Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDRPBT | Active comparator | Radiation: LDR BrachytherapyPatients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied. |
| HDRPBT | Experimental | Radiation: HDR BrachytherapyPatients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Eastern Cooperative Oncology Group (ECOG) status <=1
- 40-75 years old
- expected life expectancy>10 years
- low risk prostate cancer (Prostate specific antigen (PSA)<=10ng/ml, gleason score <7, T status<=2a), less than 50 % positive biopsy cores
- selected intermediate prostate cancer (PSA)=10-<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
Key exclusion criteria (6 listed)
- <40 years or >75 years old
- PSA>15 ng/ml gleason score 4+3 , score 8-10
- ECOG>=2
- T3-4
- percent core positivity >50 %
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 |
|---|---|---|
| LDR BrachytherapyAlso: Seed brachytherapy, Permanent implantation prostate brachytherapyIn spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy. | Radiation | LDRPBT |
| HDR BrachytherapyAlso: temporary implantIn spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied. | Radiation | HDRPBT |
Primary outcome
Acute side effects
Time frame: 6 months
Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale
Chronic side effects
Time frame: from 6 months to five year
Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale
5 secondary outcomes
quality of life
Time frame: 5 years
quality of life
Time frame: 5 years
Biochemical relapse free survival (bRFS)
Time frame: 5 years
Locoregional tumor free survival
Time frame: 5 years
Disease specific survival (DSS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
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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.
Csaba Polgar, MD, PHD contact
Peter Agoston, MD, PHD principal investigator
NIO, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LDR Brachytherapy and HDR Brachytherapy in people with Adenocarcinoma of Prostate, run by National Institute of Oncology, Hungary at 1 site in Hungary.
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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Agoston, MD PHD (+361 2248600 ext. 3186, agoston.p@oncol.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute side effects (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Oct 2014.