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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will study if giving men at risk of prostate cancer recurrence 1 year of hormone therapy after surgery will improve outcomes.
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.Check my eligibility
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.See study design
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 belowSelect...
My risk of prostate cancer returning within 5 years after surgery is 25% or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of enrolment
Secondary outcome measures
Completeness of study assessments
Proportion of patients completing study intervention per-protocol
Rate of enrolment per site
+1 moreSide effects data
From 2019 Phase 2 trial • 72 Patients • NCT0205921380%
Hot flashes
60%
Fatigue
35%
Edema limbs
35%
Pain in extremity
30%
Weight gain
30%
Arthralgia
25%
Back pain
20%
Gynecomastia
20%
Insomnia
20%
Cough
20%
Pain
20%
Alopecia
20%
Skin and subcutaneous tissue disorders - Other
20%
Nausea
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hypophosphatemia
20%
Dizziness
20%
Anemia
20%
Hypercalcemia
15%
Depression
15%
Flu like symptoms
15%
Musculoskeletal and connective tissue disorder - Other
15%
Psychiatric disorders - Other
15%
Hematuria
15%
Urinary frequency
15%
Creatinine increased
15%
Aspartate aminotransferase increased
15%
Arthritis
15%
Paresthesia
15%
Anxiety
10%
Upper respiratory infection
10%
Sinus bradycardia
10%
Erectile dysfunction
10%
Dyspnea
10%
Irritability
10%
Diarrhea
10%
Allergic rhinitis
10%
Sinusitis
10%
Urinary tract pain
10%
Infections and infestations - Other
10%
Hypertension
10%
Abdominal pain
10%
Dry mouth
10%
Vomiting
10%
Pharyngitis
10%
Injury, poisoning and procedural complications - Other
10%
Libido decreased
10%
Cystitis noninfective
10%
Sore throat
10%
Weight loss
10%
Hyperkalemia
10%
Headache
10%
Syncope
10%
Constipation
10%
Gastrointestinal disorders - Other
10%
Bloating
10%
General disorders and administration site conditions - Other
10%
Investigations - Other
5%
Hypotension
5%
Bone pain
5%
Concentration impairment
5%
Blood bilirubin increased
5%
Buttock pain
5%
White blood cell decreased
5%
Breast pain
5%
Rash maculo-papular
5%
Vestibular disorder
5%
Fever
5%
Non-cardiac chest pain
5%
Scrotal infection
5%
Nail infection
5%
Stomach pain
5%
Generalized muscle weakness
5%
Hypoglycemia
5%
Testicular pain
5%
Vascular disorders - Other
5%
Urinary tract infection
5%
Acute kidney injury
5%
Hypoxia
5%
Ear and labyrinth disorders - Other
5%
Eye disorders - Other
5%
Dental caries
5%
Dyspepsia
5%
Spinal fracture
5%
Lymphocyte count decreased
5%
Myalgia
5%
Osteoporosis
5%
Renal and urinary disorders - Other
5%
Urinary retention
5%
Sinus disorder
5%
Dry skin
5%
General disorders and administration site conditions - Other, specify
5%
Cardiac disorders - Other
5%
Dehydration
5%
Joint range of motion decreased
5%
Neck pain
5%
Nasal congestion
5%
Photosensitivity
5%
Dry eye
5%
Gait disturbance
5%
Toothache
5%
Alkaline phosphatase increased
5%
Hypoalbuminemia
5%
Hyponatremia
5%
Metabolism and nutrition disorders - Other
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Nervous system disorders - Other
5%
Fall
5%
Fracture
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®
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
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,787,677 Total Patients Enrolled
2 Trials studying Prostate Cancer
335 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My risk of prostate cancer returning within 5 years after surgery is 25% or higher.I am allergic to some forms of hormone therapy for cancer.My PSA levels were undetectable after surgery.I do not want to receive hormone therapy for cancer.I have previously undergone androgen deprivation therapy.My cancer has spread to my lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this medical investigation at present?
"Per clinicaltrials.gov, this trial is still seeking enrollees. It was first made public on March 6th 2023 and its details have been updated most recently on the 21st of March in that same year."
Answered by AI
What potential risks are associated with the combination of traditional treatments and Androgen Deprivation Therapy (Lupron Depot)?
"There is evidence of efficacy and safety in previous trials, so Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) was assigned a score of 3."
Answered by AI
How many subjects are included in this clinical trial?
"Affirmative. The details listed on clinicaltrials.gov demonstrate that this medical investigation is currently enlisting participants, with the initial post being published on 6th March 2023 and an update to the listing occurring just recently on 21st March 2023. 40 individuals are sought from 1 site for this trial."
Answered by AI
How successful have prior investigations been in combining Standard of Care and Androgen Deprivation Therapy (Lupron Depot)?
"Currently, 62 clinical trials are being carried out to research the efficacy of Standard of Care plus Androgen Deprivation Therapy (Lupron Depot). Of these studies, 24 have reached Phase 3. Most of them are located in Duarte, California; however there exist 5474 additional sites running this trial worldwide."
Answered by AI
What kind of medical cases does the combination of Standard of Care and Androgen Deprivation Therapy (Lupron Depot) usually treat?
"Androgen Deprivation Therapy (Lupron Depot) combined with Standard of Care is a viable treatment for advanced prostate cancer. In addition, it has been found to alleviate the symptoms of iron deficiency anemia, central precocious puberty (cpp), and other maladies conclusively diagnosed by clinical features."
Answered by AI
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