Prostate CancerNCT01583920
Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer
A study testing focal salvage HDR prostate brachytherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. 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?
- focal salvage HDR prostate brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Jul 2028
- 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
- Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
- Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
- Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
- American Urological Association Symptom Index Score (ie. IPSS) < 15
- Baseline (post-XRT) serum PSA < 10 ng/mL
- Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
- ECOG performance status 0-1
Who cannot join
- Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
- Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Pilot Study of Focal Salvage HDR Prostate Brachytherapy
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.
- Conditions
- Prostate Cancer
- Being tested
- focal salvage HDR prostate brachytherapy
- Keywords
- prostatic neoplasms, brachytherapy, salvage therapy, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focal salvage HDR prostate brachytherapyRadiation
Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.
| Study group | Role | What they receive |
|---|---|---|
| Focal salvage HDR prostate brachytherapy | Experimental | Not described Receives: Radiation: focal salvage HDR prostate brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute urinary and rectal toxicities
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Acute period (<6 months)
Secondary outcomes (4)
Incidence of late urinary and rectal toxicities
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Late period (>6 months)
Biochemical (ie. prostate specific antigen) disease free survival
Measured: 5 years
Quality of Life (QoL)
Expanded Prostate Cancer Index Composite (EPIC)
Measured: 5 years
Acute and late urinary toxicities
American Urological Association Symptom Index Score (i.e. IPSS)
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 posted24 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology
- Responsible party
- Principal investigator, Dr. Hans Chung, Sunnybrook Health Sciences Centre
- Investigators
- Hans Chung, MD, Principal investigator, Sunnybrook Health Sciences Centre, Odette Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583920
- Sponsor's protocol ID
- clinicaltrials_hchu_042012
- Status last verified
- Nov 2024
- First submitted
- 20 Apr 2012
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Paulin G, Morton G, Loblaw A, Tseng CL, Corkum M, Murgic J, Ravi A, Davidson M, Wronski M, Paudel M, Haider M, Deabreu A, Zhang L, Chung HT. Updated results of MR-assisted focal salvage HDR prostate brachytherapy: a prospective study. Radiother Oncol. 2025 Oct;211:111091. doi: 10.1016/j.radonc.2025.111091. Epub 2025 Aug 9.
PubMed 40789422
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Focal Salvage HDR Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT01583920
- Acronym / sponsor ID
- clinicaltrials_hchu_042012
- Conditions
- Prostate Cancer
- Keywords
- prostatic neoplasms, brachytherapy, salvage therapy, recurrent prostate cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology
- Study start
- Jul 2012
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- 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.
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal salvage HDR prostate brachytherapy | Experimental | Radiation: focal salvage HDR prostate brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
- Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
- Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
- American Urological Association Symptom Index Score (ie. IPSS) < 15
- Baseline (post-XRT) serum PSA < 10 ng/mL
Key exclusion criteria (2 listed)
- Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
- Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.
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 |
|---|---|---|
| focal salvage HDR prostate brachytherapyTreatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart. | Radiation | Focal salvage HDR prostate brachytherapy |
Primary outcome
Incidence of acute urinary and rectal toxicities
Time frame: Acute period (<6 months)
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
4 secondary outcomes
Incidence of late urinary and rectal toxicities
Time frame: Late period (>6 months)
Biochemical (ie. prostate specific antigen) disease free survival
Time frame: 5 years
Quality of Life (QoL)
Time frame: 5 years
Acute and late urinary toxicities
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 27 Nov 2024.
- Derived from this study: PubMed 40789422Paulin G, Morton G, Loblaw A, Tseng CL, Corkum M, Murgic J, Ravi A, Davidson M, Wronski M, Paudel M, Haider M, Deabreu A, Zhang L, Chung HT. Updated results of MR-assisted focal salvage HDR prostate brachytherapy: a prospective study. Radiother Oncol. 2025 Oct;211:111091. doi: 10.1016/j.radonc.2025.111091. Epub 2025 Aug 9.
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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. This study is not recruiting at the moment.
Hans Chung, MD principal investigator
Sunnybrook Health Sciences Centre, Odette Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focal salvage HDR prostate brachytherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute urinary and rectal toxicities (time frame: Acute period (<6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583920, which also lists 1 linked publication.
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 27 Nov 2024.