Salvage HDR for Locally Recurrent Prostate Cancer
PROSALBRA
Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Apr 2021
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2035
ExpectedJuly 21, 2021
July 1, 2021
3.9 years
January 7, 2020
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time to castration-resistant prostate cancer
The time from intervention until the prostate cancer becomes castration resistant
10 years
Secondary Outcomes (3)
Erectile dysfunction
5 years
Urinary symptoms
5 years
Bowel symptoms
5 years
Study Arms (1)
Single arm
EXPERIMENTALSingle arm
Interventions
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oncology
Aarhus, Region Midt, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 18, 2020
Study Start
April 1, 2021
Primary Completion
March 1, 2025
Study Completion (Estimated)
March 1, 2035
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share