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Prostatic NeoplasmPhase 2BRAchySABRNCT04523896

HDR Brachytherapy Plus Stereotactic Ablative Prostate Radiotherapy for Patients With Intermediate and High-risk Prostate Cancer

A Phase 2 study testing Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy in people with Prostatic Neoplasm, run by David Büchser at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the delivery of higher radiation doses per fraction could theoretically improve the efficacy of the treatment. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasm
What is being tested?
Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
1 Jul 2019to Jul 2023
Phase
Phase 2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate.
  • Intermediate or high-risk disease (as per NCCN criteria):
  • Intermediate risk:
  • Clinical stage ≤ T2c
  • Gleason score 7 and initial PSA ≤ 20 ng/ml.
  • Gleason score ≤ 6 and initial PSA > 10 and ≤ 20 ng/ml.
Show all 15Show fewer
  • High risk,at least one of the following:
  • Clinical stage T3a-b.
  • Gleason score 8-10.
  • Initial PSA > 20 ng/ml.
  • Life expectancy of more than 10 years
  • Able and willing to complete Expanded Prostate Index Composite (EPIC) end EORTC questionnaires
  • Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
  • Willing to give informed consent to participate in this clinical trial
  • Give competent informed consent to participate in this trial.

Who cannot join

  • Documented nodal or distant metastases.
  • Previous pelvic radiotherapy.
  • Clinical stage T4.
  • Clinical stage T3a or T3b in which the coverture of the extraprostatic disease is not feasible (as deemed by the treating physician).
  • Prostate volume > 70 cc (measured on MRI).
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >17
  • Contra-indication to radical prostate radiotherapy
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Trial locations and contacts

1 site in 1 country.

David Büchser, MD contact

+34946006000 ext. 6232

david.buechsergarcia@osakidetza.eus

Spain1 site, 1 recruiting

  • Biocruces Bizkaia Health Research Institute/Cruces University Hospital

    Barakaldo, Bizkaia, 48903

    David Büchser, MD, +34946006000 ext. 6232, david.buechsergarcia@osakidetza.eus

    Recruiting

Other trials in Spain

About this study

Official title: High-Dose-Rate Prostate Brachytherapy Combined With Stereotactic Ablative Prostate Radiotherapy for Patients Diagnosed With Intermediate and High-risk Prostate Cancer. Phase II Clinical Trial.

Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the delivery of higher radiation doses per fraction could theoretically improve the efficacy of the treatment. In this context, the combination of prostate brachytherapy and external beam radiotherapy (EBRT) has proven to be the most effective method of dose escalation significantly improving disease control in randomized clinical trials. Unfortunately, this strategy is also associated with an increased risk of acute and late adverse events compared to conventional EBRT alone. It has been proposed that this increase in adverse events could be related to the use Low-Dose-Rate (LDR) brachytherapy and that High-Dose-Rate (HDR) brachytherapy (a more modern and accurate procedure) could reduce this risk.

On the other hand, Stereotactic Ablative Radiotherapy (SABR) is a high-precision radiation technique that allows the delivery of higher doses per fraction in fewer sessions, reducing the total treatment time.

Read more

The investigators hypothesized that the combination of two highly conformal radiation techniques (HDR brachytherapy and SABR) could be well tolerated, while reducing total treatment time and therefore improving patient quality of life.

This is a single arm Phase II clinical trial designed to test the feasibility, tolerability and impact on quality of life of the combination of High-Dose-Rate prostate brachytherapy and SABR for patients with intermediate and high-risk prostate cancer.

Being tested
Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy
Keywords
High-Dose-Rate brachytherapy, SABR, SBRT, Quality of life
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapyRadiation

    Also called HDR brachytherapy, SABR, SBRT

    • Brachytherapy: Real time HDR prostate brachytherapy using a MRI-trans-rectal ultrasound image fusion protocol: single fraction of 15 Gy.

    Planning software: Oncentra prostate (Nucletron)

    • External beam radiotherapy: Stereotactic ablative radiation therapy (SABR): 5 session in 5 consecutive days, 5 Gy per fraction to the prostate.

    Intra-fraction gold seeds monitoring using Auto beam Hold solution (Varian) Planning software: Eclipse (Varian).

Study groups in NCT04523896
Study groupRoleWhat they receive
HDR brachytherapy + SABRExperimentalHigh-Dose-Rate prostate brachytherapy: a single fraction of 15 Gy to the whole prostate. Between 2-4 weeks after the brachytherapy session, SABR treatment will be delivered: 5 sessions of 5 Gy in consecutive days (i.e monday to friday) to a total dose of 25 Gy to the whole prostate.
Receives: Radiation: Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deterioration of patient quality of life as assessed by EPIC-26 (The Expanded Prostate Cancer Index Composite short form)

    Impact on Quality of life affecting the genitourinary, gastrointestinal, sexual and hormonal domains using the EPIC-26 short form (graded from 0-100, with higher scores representing better quality of life). Baseline value (i.e. prior to treatment) will be compared to values recorded 1 month, 3 months, 12 months and 24 months after treatment.

    Measured: 24 months

  2. Deterioration of patient quality of life as assessed by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-PR25 short form.

    Impact on Quality of life affecting the genitourinary, gastrointestinal, sexual and hormonal domains using the EORTC QLQ-PR25 short form (items and scale scores of the QLQ-PR25 are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of functioning (sexual).). Baseline value (i.e. prior to treatment) will be compared to values recorded 1 month, 3 months, 12 months and 24 months after treatment.

    Measured: 24 months

  3. Incidence and severity of genitourinary treatment-related acute adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.

    Every urinary event occurring within 3 months from treatment completion will be defined as "acute event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)

    Measured: 3 months

  4. Incidence and severity of gastrointestinal treatment-related acute adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.

    Every gastrointestinal event occurring within 3 months from treatment completion will be defined as "acute event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)

    Measured: 3 months

  5. Incidence and severity of genitourinary treatment-related late adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.

    Every genitourinary event occurring 3 months after treatment completion will be defined as "late event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes) 6 months, 12 months and 24 months after treatment.

    Measured: 24 months months

  6. Incidence and severity of gastrointestinal treatment-related late adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.

    Every gastro-intestinal event occurring 3 months after treatment completion will be defined as "late event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes) 6 months, 12 months and 24 months after treatment.

    Measured: 24 months months

Secondary outcomes (1)

  1. Treatment efficacy in biochemical control measured through PSA (prostate specific antigen) level.

    PSA will be evaluated at baseline and in every follow-up visit (1 month, 3 months, 6 months, 12 months and 24 months after treatment completion.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start1 Jul 2019
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523896
Sponsor's protocol ID
BRAchySABR
Acronym
BRAchySABR
Status last verified
Aug 2020
First submitted
11 Aug 2020
Last updated
24 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy in people with Prostatic Neoplasm, run by David Büchser at 1 site in Spain.

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 15 inclusion and 8 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 24 Aug 2020. 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 Spain. 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 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.

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 David Büchser, MD (+34946006000 ext. 6232, david.buechsergarcia@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deterioration of patient quality of life as assessed by EPIC-26 (The Expanded Prostate Cancer Index Composite short form) (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523896.

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 24 Aug 2020.

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