What side effects are associated with this type of intervention?

Androgen Deprivation Therapy (ADT) for prostate cancer, which reduces androgen levels to inhibit cancer cell growth, has several side effects. These include hot flashes, fatigue, loss of libido, decreased muscle mass, mild anemia, cognitive changes, and osteoporosis. ADT can also lead to weight gain, increased risk of diabetes mellitus, cardiac disease, and metabolic syndrome, significantly impacting the quality of life.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of prostate cancer that utilize Androgen Deprivation Therapy (ADT) mechanisms. These include GnRH agonists like leuprolide (Lupron) and goserelin (Zoladex), which reduce androgen production by the testes. Additionally, anti-androgens such as bicalutamide (Casodex) and enzalutamide (Xtandi) block androgen receptors on prostate cancer cells. Abiraterone (Zytiga) inhibits androgen production from all sources, including the adrenal glands and the tumor itself. These treatments aim to lower androgen levels or block their effects, thereby inhibiting the growth of prostate cancer cells.

What other types of research exist?

Promising novel alternatives to ADT for prostate cancer patients include: 1) Enzalutamide, which is an androgen receptor inhibitor that has shown improved survival rates in metastatic hormone-sensitive prostate cancer. 2) Intermittent Androgen Deprivation (IAD), which involves cycles of ADT followed by breaks to reduce side effects and potentially delay resistance. 3) Bipolar Androgen Therapy (BAT), which alternates between high and low testosterone levels to potentially restore sensitivity to other treatments. These alternatives offer different mechanisms or strategies to manage prostate cancer while aiming to reduce the adverse effects associated with continuous ADT.

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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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Renal and urinary disorders - Other

Nail infection

Neck pain

Eye disorders - Other

Hypoxia

Cardiac disorders - Other

Dry eye

Urinary tract infection

Ear and labyrinth disorders - Other

Fever

General disorders and administration site conditions - Other, specify

Vestibular disorder

Acute kidney injury

Dental caries

Dyspepsia

Stomach pain

Toothache

Non-cardiac chest pain

Gait disturbance

Fall

Scrotal infection

Fracture

Alkaline phosphatase increased

Lymphocyte count decreased

White blood cell decreased

Spinal fracture

Blood bilirubin increased

Dehydration

Hypoalbuminemia

Hypoglycemia

Hyponatremia

Bone pain

Buttock pain

Joint range of motion decreased

Metabolism and nutrition disorders - Other

Generalized muscle weakness

Myalgia

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other

Concentration impairment

Osteoporosis

Nervous system disorders - Other

Urinary retention

Breast pain

Testicular pain

Dry skin

Photosensitivity

Rash maculo-papular

Nasal congestion

Sinus disorder

Hypotension

Vascular disorders - Other

Peripheral sensory neuropathy

Vertigo

Sepsis

Small intestinal obstruction

Hearing impaired

Blood and lymphatic system disorders - Other

Rectal hemorrhage

Hypertriglyceridemia

Hypomagnesemia

Hypernatremia

Memory impairment

Respiratory, thoracic and mediastinal disorders - Other

Pruritus

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

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.