NCT02342054

Brief Summary

High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in terms of biochemical control, patient survival and toxicity, but there are still certain limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical trial. The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of cancer control and satisfaction of the patients undergoing the experimental treatment. Forty nine patients will be recruited for the experimental procedure Quality of Life, tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized procedures and scales. Patient satisfaction with the procedure will be appraised using five-category predetermined Likert scale questions. Two different types of intermediate analyses will be performed: with 15 and 30 recruited patients. The experimental treatment tested in this study is very innovative. Since prostate cancer is the most frequent cancer in men in Spain, this trial results are very likely to have a major impact on the standard therapy for prostate cancer in our National Health Service, allowing for a higher number of Hospitals within our country and other countries starting protocols of HDR BT 19Gy in single fraction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

January 12, 2015

Last Update Submit

January 16, 2015

Conditions

Prostate Cancer

Keywords

CancerProstate CancerBrachytherapyDose escalationHigh Dose RateMRI-TRUS fusionDetection of DILs by MRISINGLE FRACTION

Outcome Measures

Primary Outcomes (2)

  • Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize

    Data to be collected are: i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize

    12 months

  • Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC

    Quality of life will be measured through validated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC

    12 months

Secondary Outcomes (3)

  • Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity

    24 months

  • Efficacy, measured by PSA

    24 months

  • Patient satisfaction measured with Likert scale question

    24 months

Study Arms (1)

MRI-TRUS fusion guided Single Frac HDR

EXPERIMENTAL

Patients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)

Radiation: MRI-TRUS fusion guided Single Frac HDR

Interventions

MRI-TRUS fusion guided Single Frac HDRRADIATION
Also known as: Single Fraction real time HDR (19Gy), Planning software Oncentra Prostate for Nucletron
MRI-TRUS fusion guided Single Frac HDR

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men older than 18 years old
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Clinical stage T1c/T2a disease
  • Low and Intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA \< 20 ng/ml.
  • Prostate volume \< 60 cc as determined by ultrasound, CT or MRI
  • Life expectancy of more than 10 years
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
  • Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
  • Give competent informed consent to participate in this trial.

You may not qualify if:

  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
  • Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors is permitted
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>19
  • Contra-indication to radical prostate radiotherapy
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Cruces

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Related Publications (1)

  • Gomez-Iturriaga A, Casquero F, Pijoan JI, Minguez P, Espinosa JM, Irasarri A, Bueso A, Cacicedo J, Buchser D, Bilbao P. Health-related-quality-of-life and toxicity after single fraction 19 Gy high-dose-rate prostate brachytherapy: Phase II trial. Radiother Oncol. 2018 Feb;126(2):278-282. doi: 10.1016/j.radonc.2017.10.039. Epub 2017 Nov 15.

    PMID: 29153462DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Alfonso Gomez-Iturriaga, MD, PhD

    Hospital Universitario Cruces/Biocruces

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Gomez-Iturriaga, MD, PhD

CONTACT

946006233ALFONSO.GOMEZDEITURRIAGAPINA@osakidetza.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff physician department of Radiation Oncology

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2017

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

ES(1)