Prostate CancerPROSALBRANCT04231006
Salvage HDR for Locally Recurrent Prostate Cancer
A study testing High dose rate brachytherapy in people with Prostate Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High dose rate brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 1 Mar 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology
Aarhus, Region Midt, 8200
Simon Buus, 40465291, simbuu@rm.dk
About this study
Official title: 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
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- High dose rate brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose rate brachytherapyRadiation
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single arm Receives: Radiation: High dose rate brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to castration-resistant prostate cancer
The time from intervention until the prostate cancer becomes castration resistant
Measured: 10 years
Secondary outcomes (3)
Erectile dysfunction
Erectile dysfunction as reported by patients in CTCAE PRO
Measured: 5 years
Urinary symptoms
Urinary symptoms as reported by patients in CTCAE PRO
Measured: 5 years
Bowel symptoms
Bowel symptoms as reported by patients in CTCAE PRO
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Apr 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Buus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231006
- Sponsor's protocol ID
- 1-10-72-218-19
- Acronym
- PROSALBRA
- Status last verified
- Jul 2021
- First submitted
- 7 Jan 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT04231006
- Acronym / sponsor ID
- PROSALBRA / 1-10-72-218-19
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2035 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: High dose rate brachytherapySingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose rate brachytherapyHigh dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT | Radiation | Single arm |
Primary outcome
Time to castration-resistant prostate cancer
Time frame: 10 years
The time from intervention until the prostate cancer becomes castration resistant
3 secondary outcomes
Erectile dysfunction
Time frame: 5 years
Urinary symptoms
Time frame: 5 years
Bowel symptoms
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose rate brachytherapy in people with Prostate Cancer, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Buus, MD (+4540465291, simbuu@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to castration-resistant prostate cancer (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.