Biochemical Relapse Free SurvivalNCT04870567
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer
A study testing Stereotactic ablative radiotherapy and High dose rate brachytherapy in people with Biochemical Relapse Free Survival and Complications Rates (Erectile Dysfunction, GI, GU Complications), run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Biochemical Relapse Free Survival, Complications Rates (Erectile Dysfunction, GI, GU Complications)
- What is being tested?
- Stereotactic ablative radiotherapy and High dose rate brachytherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2018to Apr 2025
- 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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO performance status of 0-2,
- histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0
- T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA
- PSA below 20 ng/ml within the last 30 days
- international prostate index score (IPSS) below 16
- medically fit to spinal anesthesia
Show all 9Show fewer
- prostate volume below 110 cm³
- maximal urinary rate above 9 ml/sec, residual urine volume below 30ml,
- in the case of previous transurethral resection interval of at least 9 months after procedure.
Who cannot join
- stage T3-T4,
- PSA > 20 ng/ml,
- clinically detected lymph node or distant metastases,
- previous pelvic irradiation,
- rectal surgery.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Sergey Novikov
Saint Petersburg, 197758
Sergey Novikov, +7-9500437996, krokon@mail.ru
About this study
Official title: High Dose Rate Brachytherapy vs Stereotactic Ablative Body Therapy in Patients With Early-intermediate Prostate Cancer
This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients.
Read the detailed description
Before SBRT three fiducial markers are obligatory inserted into the prostate. Simulation and every SBRT sessions are performed after bowel preparation (enema) and bladder filling (400ml).Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. The clinical target volume (CTV) include the prostate only (low-risk patients) or prostate and proximal 1/3 of seminal vesicles (intermediate-risk patients). CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted.
All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.
After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2).
Patients are assessed during treatment, 4-12 weeks after the end of the treatment, every 3 months for the first year and then every 6 months till the end of the study. Normal tissue adverse events are reported according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). International prostate symptoms score (IPSS) and international index of erectile function (IIEF-5) must be assessed on each visit, maximal urinary rate and residual urine volume - annually.
- Conditions
- Biochemical Relapse Free Survival, Complications Rates (Erectile Dysfunction, GI, GU Complications)
- Being tested
- Stereotactic ablative radiotherapy, High dose rate brachytherapy
- Keywords
- brachytherapy, stereotactic ablative radiotherapy, survival, complications
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative radiotherapyRadiation
Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).
High dose rate brachytherapyRadiation
Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).
| Study group | Role | What they receive |
|---|---|---|
| High dose rate brachytherapy | Active comparator | After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2). Receives: Radiation: High dose rate brachytherapy |
| Stereotactic ablative radiotherapy | Experimental | Before SBRT three fiducial markers are obligatory inserted into the prostate.Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted.
All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional. Receives: Radiation: Stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grade 3-5 Adverse Events Assessed by Common Terminology Criteria for Adverse Events CTCAE v5
To evaluate frequency of grade 3-5 toxicity in patients treated by high dose rate brachutherapy (arm 1) and stereotactic ablative radiotherapy (arm 2)
Measured: 5 years after treatment
Change in the proportion of patients with moderate and severe erectile dysfunction
Assessed by International Index of Erectile Function (IIEF)
Measured: 3, 6, 12, 18, 24 and every 6 months through 5 years
Secondary outcomes (1)
Biochemical relapse free survival
PSA levels in the blood. Reccurence - nadir + 2 ng/ml
Measured: 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Apr 2018
- Primary completionApr 2023 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical Relapse Free SurvivalStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galina Kireeva, N.N. Petrov National Medical Research Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870567
- Sponsor's protocol ID
- 03
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Rate Brachytherapy vs Stereotactic Ablative Body Therapy in Patients With Early-intermediate Prostate Cancer
- ClinicalTrials.gov ID
- NCT04870567
- Acronym / sponsor ID
- 03
- Conditions
- Biochemical Relapse Free Survival, Complications Rates (Erectile Dysfunction, GI, GU Complications)
- Keywords
- brachytherapy, stereotactic ablative radiotherapy, survival, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 3 May 2021 (actual)
- 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.
This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients.
Detailed description
Before SBRT three fiducial markers are obligatory inserted into the prostate. Simulation and every SBRT sessions are performed after bowel preparation (enema) and bladder filling (400ml).Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. The clinical target volume (CTV) include the prostate only (low-risk patients) or prostate and proximal 1/3 of seminal vesicles (intermediate-risk patients). CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted.
All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.
After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2).
Patients are assessed during treatment, 4-12 weeks after the end of the treatment, every 3 months for the first year and then every 6 months till the end of the study. Normal tissue adverse events are reported according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). International prostate symptoms score (IPSS) and international index of erectile function (IIEF-5) must be assessed on each visit, maximal urinary rate and residual urine volume - annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose rate brachytherapy | Active comparator | Radiation: High dose rate brachytherapyAfter spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2). |
| Stereotactic ablative radiotherapy | Experimental | Radiation: Stereotactic ablative radiotherapyBefore SBRT three fiducial markers are obligatory inserted into the prostate.Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted. All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- WHO performance status of 0-2,
- histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0
- T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA
- PSA below 20 ng/ml within the last 30 days
- international prostate index score (IPSS) below 16
Key exclusion criteria (5 listed)
- stage T3-T4,
- PSA > 20 ng/ml,
- clinically detected lymph node or distant metastases,
- previous pelvic irradiation,
- rectal surgery.
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 |
|---|---|---|
| Stereotactic ablative radiotherapyPatients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate). | Radiation | Stereotactic ablative radiotherapy |
| High dose rate brachytherapyPatients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate). | Radiation | High dose rate brachytherapy |
Primary outcome
Number of grade 3-5 Adverse Events Assessed by Common Terminology Criteria for Adverse Events CTCAE v5
Time frame: 5 years after treatment
To evaluate frequency of grade 3-5 toxicity in patients treated by high dose rate brachutherapy (arm 1) and stereotactic ablative radiotherapy (arm 2)
Change in the proportion of patients with moderate and severe erectile dysfunction
Time frame: 3, 6, 12, 18, 24 and every 6 months through 5 years
Assessed by International Index of Erectile Function (IIEF)
1 secondary outcome
Biochemical relapse free survival
Time frame: 5 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic ablative radiotherapy and High dose rate brachytherapy in people with Biochemical Relapse Free Survival and Complications Rates (Erectile Dysfunction, GI, GU Complications), run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of grade 3-5 Adverse Events Assessed by Common Terminology Criteria for Adverse Events CTCAE v5 (time frame: 5 years after treatment). 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 3 May 2021.