Prostate CancerPhase 3NCT05169112
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
A Phase 3 study testing Lupron Depot in people with Prostate Cancer, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial summary
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. 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?
- Lupron Depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Mar 2023to Nov 2028
- Phase
- Phase 3
- 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
- undetectable PSA (<0.02 ng/ml) within 16 weeks post-operative;
- ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Who cannot join
- Unwilling to receive ADT;
- previously received ADT;
- lymph node metastases
- allergy to any form of ADT
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia, B3H 2Y9
Ricardo Rendon, MD, 902-425-3940, Ricardo.Rendon@nshealth.ca
Ricardo Rendon, Dr.
- Not yet recruiting
Centre universitaire de santé McGill - McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Rodney H Breau, MD, FRCSC, 613-737-8899 ext. 73019, rbreau@ottawahospital.on.ca
Pascale Juneau, MASc, 613-737-8899 ext. 73852, pjuneau@ohri.ca
About this study
Official title: The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.
- Conditions
- Prostate Cancer
- Being tested
- Lupron Depot
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lupron DepotDrug
Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of Care |
| Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) | Experimental | 22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total) Receives: Drug: Lupron Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrolment
Rate (patients/month) of enrolment
Measured: 1 year
Secondary outcomes (4)
Rate of enrolment per site
Rate (patients/month) of enrolment per site
Measured: 1 year
Proportion of patients completing study intervention per-protocol
Proportion of patients completing study intervention per-protocol
Measured: 1 year
Time to study start-up
Time to study start-up at each site
Measured: 1 year
Completeness of study assessments
Proportion of study assessments completed per-protocol
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start6 Mar 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (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 Ottawa Hospital Research InstituteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tolmar Pharmaceuticals
- Responsible party
- Principal investigator, Rodney Breau, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169112
- Sponsor's protocol ID
- Adjuvant ADT Pilot
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A. IPD not planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
- ClinicalTrials.gov ID
- NCT05169112
- Acronym / sponsor ID
- Adjuvant ADT Pilot
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Tolmar Pharmaceuticals
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 23 Dec 2021 (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.
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care |
| Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) | Experimental | Drug: Lupron Depot22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undetectable PSA (<0.02 ng/ml) within 16 weeks post-operative;
- ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Key exclusion criteria (4 listed)
- Unwilling to receive ADT;
- previously received ADT;
- lymph node metastases
- allergy to any form of ADT
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 |
|---|---|---|
| Lupron DepotPatients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months | Drug | Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) |
Primary outcome
Rate of enrolment
Time frame: 1 year
Rate (patients/month) of enrolment
4 secondary outcomes
Rate of enrolment per site
Time frame: 1 year
Proportion of patients completing study intervention per-protocol
Time frame: 1 year
Time to study start-up
Time frame: 1 year
Completeness of study assessments
Time frame: 1 year
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 Mar 2025.
- Individual participant dataSharing planned: No. N/A. IPD not planned to be shared
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lupron Depot in people with Prostate Cancer, run by Ottawa Hospital Research Institute at 3 sites 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 2 inclusion and 4 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 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rodney Breau, Dr. (613-737-8899 ext. 73019, rbreau@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of enrolment (time frame: 1 year). 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 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.