Salvage HDR for Locally Recurrent Prostate Cancer (PROSALBRA)

July 20, 2021 updated by: Simon Buus, Aarhus University Hospital

Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Simon Buus, MD
  • Phone Number: +4540465291
  • Email: simbuu@rm.dk

Study Locations

  • Denmark
    • Region Midt
      • Aarhus, Region Midt, Denmark, 8200
        • Recruiting
        • Department of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
  • ≥ 2 years since the end of primary radiotherapy
  • PSA recurrence Phoenix criteria (nadir + 2)
  • No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
  • MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
  • GTV identifiable on mpMRI
  • No current endocrine therapy
  • Plasma testosterone ≥1.75 nm/l
  • PSA doubling time ≥ 6 months and ≤ 24 months
  • Performance status 0-1
  • DAN PSS score ≤ 20
  • Maximal urinary flow ≥ 10 ml/s
  • Life expectancy > 5 years
  • PSA ≤ 10 ug/L at recurrence

Exclusion Criteria:

  • Pubic arc interference or major calcifications within the prostate gland.
  • Contraindication for spinal or general anaesthesia.
  • Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
  • Inflammatory bowel disease
  • Contraindications to 3T MRI
  • eGFR < 30 ml/min
  • ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Radiation: High dose rate brachytherapy
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to castration-resistant prostate cancer
Time Frame: 10 years
The time from intervention until the prostate cancer becomes castration resistant
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile dysfunction
Time Frame: 5 years
Erectile dysfunction as reported by patients in CTCAE PRO
5 years
Urinary symptoms
Time Frame: 5 years
Urinary symptoms as reported by patients in CTCAE PRO
5 years
Bowel symptoms
Time Frame: 5 years
Bowel symptoms as reported by patients in CTCAE PRO
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2035

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-218-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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