Prostate Cancer (Post Prostatectomy)NCT07132671
MRI-guided Brachytherapy and Salvage SBRT Program
A study testing Brachytherapy and MR-Guided SBRT in people with Prostate Cancer (Post Prostatectomy), run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- Brachytherapy and MR-Guided SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Jun 2030
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and RMN+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.
- Pathological confirmation is advised in all cases but it is not mandatory .
- Patients with any of the following were not considered eligible:
- Distance < 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)
- Distant Metastases
- Isolated nodal relapses
- Prior Irradiation to the IPBR area
- Multicentric IPBRs
- Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
- No prior radiation therapy to the target areas;
- Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
- WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
- Ability to undergo MRI scanning.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy
Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy
Read the detailed description
The goal of this clinical trial is to learn if the use of brachytherapy followed by MRI-guided irradiation increases the rates of tumor control and decreases the rates of adverse events in patients with tumor bed relapses after radical prostatectomy
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- Brachytherapy and MR-Guided SBRT
- Keywords
- Prostate Cancer, Prostate Bed Relapse, Brachytherapy, MR-Guided SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy and MR-Guided SBRTRadiation
HDR Brachytherapy followed by MR-guided SBRT
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided Brachytherapy and Salvage SBRT Program | Experimental | Brachytherapy and MR-guided SBRT Receives: Radiation: Brachytherapy and MR-Guided SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical control
To achieve 5-year biochemical control rate in 85% of the patients.
Measured: 5-year
Adverse Events
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Measured: 5-year
Secondary outcomes (1)
QOL
Determination of QOL with the EORTC QLQ-PR25
Measured: From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- 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
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Martínez-Monge, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de NavarraMarta Gimeno-Morales, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132671
- Sponsor's protocol ID
- 2024.224
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07132671
- Acronym / sponsor ID
- 2024.224
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Keywords
- Prostate Cancer, Prostate Bed Relapse, Brachytherapy, MR-Guided SBRT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Aug 2025 (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.
Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy
Detailed description
The goal of this clinical trial is to learn if the use of brachytherapy followed by MRI-guided irradiation increases the rates of tumor control and decreases the rates of adverse events in patients with tumor bed relapses after radical prostatectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided Brachytherapy and Salvage SBRT Program | Experimental | Radiation: Brachytherapy and MR-Guided SBRTBrachytherapy and MR-guided SBRT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Brachytherapy and MR-Guided SBRTHDR Brachytherapy followed by MR-guided SBRT | Radiation | MRI-guided Brachytherapy and Salvage SBRT Program |
Primary outcome
Biochemical control
Time frame: 5-year
To achieve 5-year biochemical control rate in 85% of the patients.
Adverse Events
Time frame: 5-year
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
1 secondary outcome
QOL
Time frame: From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter
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 20 Aug 2025.
- Individual participant dataSharing planned: Yes. On request
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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.
Rafael Martínez-Monge, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Marta Gimeno-Morales, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy and MR-Guided SBRT in people with Prostate Cancer (Post Prostatectomy), run by Clinica Universidad de Navarra, Universidad de Navarra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Beatriz Ramos Aguirre, M.S. (+34948255400 ext. 2772, ucicec@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical control (time frame: 5-year). The study lists 2 primary outcomes in all. 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 20 Aug 2025.