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Salvage HDR for Locally Recurrent Prostate Cancer (PROSALBRA)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High dose rate brachytherapy
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of OncologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Single arm

Outcomes

Primary Outcome Measures

Time to castration-resistant prostate cancer
The time from intervention until the prostate cancer becomes castration resistant

Secondary Outcome Measures

Erectile dysfunction
Erectile dysfunction as reported by patients in CTCAE PRO
Urinary symptoms
Urinary symptoms as reported by patients in CTCAE PRO
Bowel symptoms
Bowel symptoms as reported by patients in CTCAE PRO

Full Information

First Posted
January 7, 2020
Last Updated
July 20, 2021
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04231006
Brief Title
Salvage HDR for Locally Recurrent Prostate Cancer
Acronym
PROSALBRA
Official Title
Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Radiation
Intervention Name(s)
High dose rate brachytherapy
Intervention Description
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
Primary Outcome Measure Information:
Title
Time to castration-resistant prostate cancer
Description
The time from intervention until the prostate cancer becomes castration resistant
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Erectile dysfunction
Description
Erectile dysfunction as reported by patients in CTCAE PRO
Time Frame
5 years
Title
Urinary symptoms
Description
Urinary symptoms as reported by patients in CTCAE PRO
Time Frame
5 years
Title
Bowel symptoms
Description
Bowel symptoms as reported by patients in CTCAE PRO
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Buus, MD
Phone
+4540465291
Email
simbuu@rm.dk
Facility Information:
Facility Name
Department of Oncology
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Buus
Phone
40465291
Email
simbuu@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Salvage HDR for Locally Recurrent Prostate Cancer

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