Prostate Cancer RecurrentSHAPE-PSMANCT06508567
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
A study testing High Dose Rate Brachytherapy in people with Prostate Cancer Recurrent and Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent, 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
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Aug 2024to 1 Mar 2031
- 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
- Patients who received previous RT to the prostate bed +/- pelvic nodal regions
- Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
- At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
- With or without ADT PSA doubling time from nadir greater than 6 months
- ECOG 0-2
- Age greater than 18 years
Who cannot join
- Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
- History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
- Any contraindications to MR and/or brachytherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G1Z5
Peter Chung, 416-946-4501 ext. 3374, peter.chung@uhn.ca
About this study
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.
Read the detailed description
Patients who received previous adjuvant or salvage radiotherapy to the prostate bed >
Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible >
Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning >
Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) >
Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)
- Conditions
- Prostate Cancer Recurrent, 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
2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).
| Study group | Role | What they receive |
|---|---|---|
| 2xHDR Brachytherapy | Experimental | Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy. Receives: Radiation: High Dose Rate Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry Parameters
As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
Measured: 5 Years
Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3
Measured: 5 Years
Secondary outcomes (3)
Biochemical Control assessed by PSA
Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment.
Measured: 5 Years
Local Disease Control
Assessed by MRI/PSMA-PET imaging at 2 years
Measured: 2 Years
Changes in Quality of Life
Assessed with EPIC Quality of Life scores yearly for 5 years.
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 Jul 2024
- Study start8 Aug 2024
- Primary completion8 Aug 2028 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508567
- Sponsor's protocol ID
- 23-6023
- Acronym
- SHAPE-PSMA
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
- ClinicalTrials.gov ID
- NCT06508567
- Acronym / sponsor ID
- SHAPE-PSMA / 23-6023
- Conditions
- Prostate Cancer Recurrent, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 8 Aug 2028 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 18 Jul 2024 (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.
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.
Detailed description
Patients who received previous adjuvant or salvage radiotherapy to the prostate bed >
Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible >
Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning >
Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) >
Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2xHDR Brachytherapy | Experimental | Radiation: High Dose Rate BrachytherapySalvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who received previous RT to the prostate bed +/- pelvic nodal regions
- Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
- At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
- With or without ADT PSA doubling time from nadir greater than 6 months
- ECOG 0-2
Key exclusion criteria (3 listed)
- Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
- History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
- Any contraindications to MR and/or brachytherapy
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 Brachytherapy2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days). | Radiation | 2xHDR Brachytherapy |
Primary outcome
Dosimetry Parameters
Time frame: 5 Years
As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
Time frame: 5 Years
Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3
3 secondary outcomes
Biochemical Control assessed by PSA
Time frame: 5 Years
Local Disease Control
Time frame: 2 Years
Changes in Quality of Life
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 20 Oct 2026.
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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 Recurrent and Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 3 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 20 Oct 2026. 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 Canada. 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 Peter Chung, MD (416-946-4501 ext. 3374, peter.chung@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry Parameters (time frame: 5 Years). 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 Oct 2026.