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Hormonal Therapy for Post-Surgery Prostate Cancer Recurrence

Phase 3
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Be older than 18 years old
Must not have
Allergy to any form of ADT
Unwilling to receive ADT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether using treatment right after surgery can help prevent prostate cancer from coming back in men who are at high risk. The treatment works by lowering or blocking male hormones that help cancer cells grow. Treatment has been used to block male hormones required for cancer growth, and early treatment has shown to delay worsening in prostate cancer patients with intermediate or poor outlook.

Who is the study for?
Men who've had prostate cancer surgery and are at high risk of the cancer coming back can join this trial. They must have a very low PSA level after surgery and a prediction tool must show they're likely to have their cancer return within 5 years.
What is being tested?
The study is testing if giving hormonal therapy (Lupron Depot) for one year after prostate surgery can prevent the cancer from coming back. This approach is compared with usual care in men who are at high risk of recurrence.
What are the potential side effects?
Hormonal therapy like Lupron Depot may cause hot flashes, fatigue, sexual dysfunction, bone thinning, mood changes, and increased cholesterol or sugar levels in blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My risk of prostate cancer returning within 5 years after surgery is 25% or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to some forms of hormone therapy for cancer.
Select...
I do not want to receive hormone therapy for cancer.
Select...
I have previously undergone androgen deprivation therapy.
Select...
My cancer has spread to my lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of enrolment
Secondary study objectives
Completeness of study assessments
Proportion of patients completing study intervention per-protocol
Rate of enrolment per site
+1 more

Side effects data

From 2019 Phase 2 trial • 72 Patients • NCT02059213
80%
Hot flashes
60%
Fatigue
35%
Edema limbs
35%
Pain in extremity
30%
Weight gain
30%
Arthralgia
25%
Back pain
20%
Skin and subcutaneous tissue disorders - Other
20%
Nausea
20%
Pain
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hypophosphatemia
20%
Dizziness
20%
Insomnia
20%
Gynecomastia
20%
Alopecia
20%
Cough
20%
Anemia
20%
Hypercalcemia
15%
Flu like symptoms
15%
Creatinine increased
15%
Aspartate aminotransferase increased
15%
Arthritis
15%
Musculoskeletal and connective tissue disorder - Other
15%
Depression
15%
Paresthesia
15%
Psychiatric disorders - Other
15%
Hematuria
15%
Urinary frequency
15%
Anxiety
10%
Infections and infestations - Other
10%
Diarrhea
10%
Dry mouth
10%
Vomiting
10%
Abdominal pain
10%
Sinus bradycardia
10%
Irritability
10%
Pharyngitis
10%
Injury, poisoning and procedural complications - Other
10%
Sinusitis
10%
Upper respiratory infection
10%
Weight loss
10%
Hyperkalemia
10%
Syncope
10%
Headache
10%
Libido decreased
10%
Cystitis noninfective
10%
Urinary tract pain
10%
Erectile dysfunction
10%
Allergic rhinitis
10%
Sore throat
10%
Dyspnea
10%
Hypertension
10%
Constipation
10%
Gastrointestinal disorders - Other
10%
Bloating
10%
General disorders and administration site conditions - Other
10%
Investigations - Other
5%
Renal and urinary disorders - Other
5%
Nail infection
5%
Neck pain
5%
Eye disorders - Other
5%
Hypoxia
5%
Cardiac disorders - Other
5%
Dry eye
5%
Urinary tract infection
5%
Ear and labyrinth disorders - Other
5%
Fever
5%
General disorders and administration site conditions - Other, specify
5%
Vestibular disorder
5%
Acute kidney injury
5%
Dental caries
5%
Dyspepsia
5%
Stomach pain
5%
Toothache
5%
Non-cardiac chest pain
5%
Gait disturbance
5%
Fall
5%
Scrotal infection
5%
Fracture
5%
Alkaline phosphatase increased
5%
Lymphocyte count decreased
5%
White blood cell decreased
5%
Spinal fracture
5%
Blood bilirubin increased
5%
Dehydration
5%
Hypoalbuminemia
5%
Hypoglycemia
5%
Hyponatremia
5%
Bone pain
5%
Buttock pain
5%
Joint range of motion decreased
5%
Metabolism and nutrition disorders - Other
5%
Generalized muscle weakness
5%
Myalgia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Concentration impairment
5%
Osteoporosis
5%
Nervous system disorders - Other
5%
Urinary retention
5%
Breast pain
5%
Testicular pain
5%
Dry skin
5%
Photosensitivity
5%
Rash maculo-papular
5%
Nasal congestion
5%
Sinus disorder
5%
Hypotension
5%
Vascular disorders - Other
5%
Peripheral sensory neuropathy
5%
Vertigo
5%
Sepsis
5%
Small intestinal obstruction
5%
Hearing impaired
5%
Blood and lymphatic system disorders - Other
5%
Rectal hemorrhage
5%
Hypertriglyceridemia
5%
Hypomagnesemia
5%
Hypernatremia
5%
Memory impairment
5%
Respiratory, thoracic and mediastinal disorders - Other
5%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
ADT Alone
ADT + Ibrance®

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)Experimental Treatment1 Intervention
22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
Group II: Standard of CareActive Control1 Intervention
Standard of Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peracetic acid
Not yet FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for prostate cancer include Androgen Deprivation Therapy (ADT), which reduces androgen levels to inhibit prostate cancer cell growth. This can be achieved through surgical removal of the testes or medications that inhibit androgen production or block androgen receptors. Other treatments include taxane-based chemotherapy, which disrupts cell division, and second-generation androgen receptor inhibitors like enzalutamide and abiraterone, which further block androgen signaling pathways. Understanding these mechanisms is crucial for patients as it helps them comprehend how these treatments target cancer cells, potentially improving treatment outcomes and managing side effects.
Rationale for the development of alternative forms of androgen deprivation therapy.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,841 Total Patients Enrolled
2 Trials studying Prostate Cancer
335 Patients Enrolled for Prostate Cancer

Media Library

Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) Clinical Trial Eligibility Overview. Trial Name: NCT05169112 — Phase 3
Prostate Cancer Research Study Groups: Standard of Care, Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
Prostate Cancer Clinical Trial 2023: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) Highlights & Side Effects. Trial Name: NCT05169112 — Phase 3
Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169112 — Phase 3
~15 spots leftby Oct 2025