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

NCT ID: NCT04523896

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-07-31

Brief 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. 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.

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.

Conditions

Prostatic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDR brachytherapy + SABR

High-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.

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

• 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).

Interventions

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

• 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).

Intervention Type: RADIATION

Other Intervention Names

HDR brachytherapy; SABR; SBRT

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

David Büchser

OTHER_GOV

Sponsor Role: lead

Responsible Party

David Büchser

Radiation Oncology Consultant, Principal Investigator.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Büchser, MD

Role: PRINCIPAL_INVESTIGATOR

Biocruces Bizkaia Health Research Institute/ Cruces University Hospital

Alfonso Gomez-Iturriaga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Biocruces Bizkaia Health Research Institute/ Cruces University Hospital

Locations

Biocruces Bizkaia Health Research Institute/Cruces University Hospital

Barakaldo, Bizkaia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

David Büchser, MD

Role: CONTACT

david.buechsergarcia@osakidetza.eus

+34946006000 ext. 6232

Facility Contacts

David Büchser, MD

Role: primary

david.buechsergarcia@osakidetza.eus

+34946006000 ext. 6232

Other Identifiers

BRAchySABR

Identifier Type: -

Identifier Source: org_study_id