Hormone Therapy Duration for Prostate Cancer

(PCS-XII Trial)

Not yet recruiting at 4 trial locations

Overseen By Tamim Niazi, MDCM, FRCPC

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Charles LeMoyne Hospital

Must be taking: Androgen suppression

Must not be taking: Anti-arrhythmics

Disqualifiers: Other malignancies, Small-cell carcinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the optimal duration of hormone therapy for prostate cancer patients who also receive radiation therapy. It compares the effects of six months versus twelve months of hormone therapy using the drug Eligard. Participants can choose between two types of radiation treatments. Men with prostate cancer, especially those with high PSA levels or aggressive cancer cells, might be suitable for this trial. The study aims to determine which treatment duration is more effective. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that patients stop taking 5-alpha-reductase inhibitors (like Finasteride) before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Eligard, a treatment for prostate cancer, is generally safe. In past studies, many patients tolerated the treatment well. For instance, one study found that side effects like pain at the injection site were mild and resolved quickly. However, some men might experience a temporary increase in testosterone at the start, which can briefly worsen prostate cancer symptoms.

Since this clinical trial is in a later phase, earlier studies have already tested Eligard's safety, providing more evidence of its safety in humans. Individual experiences can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the hormone therapy durations for prostate cancer because they are testing different treatment lengths to optimize patient outcomes. Unlike the standard of care which often involves fixed long-term hormone therapy, this trial explores whether shorter, 6-month treatment durations might be just as effective as the traditional 12-month regimen. This approach could potentially reduce side effects and improve the quality of life for patients by minimizing the time they need to be on medication. By comparing two different treatment lengths of Eligard, an LHRH agonist, researchers hope to find the most effective and patient-friendly option.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare the effectiveness of different durations of hormone therapy using Eligard for prostate cancer. Studies have shown that Eligard effectively lowers certain hormones in prostate cancer patients. In one study, levels of prostate-specific antigen (PSA) dropped by 94%, and testosterone levels decreased by 89% after 6 months of treatment, significantly reducing the hormones that help prostate cancer grow. Real-world data also show that Eligard, when used with other treatments, effectively manages prostate cancer. This hormone therapy has been proven to help control the disease by reducing the hormones that fuel cancer cell growth. ^{2 3 6 7 8}

Who Is on the Research Team?

Georges Wakil, MDCM, FRCPC, DABR

Principal Investigator

Hopital Charles Lemoyne

Tamim Niazi, MDCM, FRCPC

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for men with a specific stage of prostate cancer called 'unfavorable intermediate-risk.' They should be fit for hormone therapy and radiation, which could include high-dose brachytherapy. Specific details on who can or cannot participate are not provided here.

Inclusion Criteria

Adequate birth control measures must be used by participants or their sexual partners

Hematology and biochemistry laboratory requirements must meet specified criteria

I started hormone therapy for cancer less than 28 days ago.

Exclusion Criteria

Presence of bilateral hip replacement prostheses

I have a heart condition called long QT syndrome or take certain heart medications.

Known hypersensitivity to any protocol-indicated study medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either 6 or 12 months of hormone therapy with concomitant radiation therapy, which may include hypofractionated radiation therapy or a combination with high-dose rate brachytherapy.

6-12 months

Follow-up

Participants are monitored for overall survival, disease-specific survival, and biochemical progression-free survival.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Eligard
• Prostate SBRT or Prostate Brachytherapy with Radiation Therapy

Trial Overview The study is testing the length of hormone therapy needed when combined with radiation treatment. Men will either receive 6 months or 12 months of Eligard, a hormonal drug, alongside their chosen form of radiation therapy.

How Is the Trial Designed?

Group I: 12 months of hormone therapy Experimental Treatment 2 Interventions

Patients will receive a total of four 3-month injections of a LHRH agonist

Group II: 6 months of hormone therapy Active Control 1 Intervention

Patients will receive a total of two 3-month injections of a LHRH agonist

Who Is Running the Clinical Trial?

Charles LeMoyne Hospital

Lead Sponsor

Trials

1

Recruited

400+

Published Research Related to This Trial

In a study involving 1,906 patients with advanced prostate cancer, both 3-month and 6-month leuprorelin acetate depot formulations significantly reduced prostate-specific antigen (PSA) levels from an average of 12.0 ng/mL to 0.5 ng/mL after 12 months, indicating effective treatment.

The treatment was well-tolerated, with only 8.8% of patients experiencing adverse events, suggesting that leuprorelin acetate is a safe option for managing advanced prostate cancer in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer. Ohlmann, CH., Gross-Langenhoff, M.[2018]

The new formulation of leuprorelin acetate (Eligard) effectively suppresses testosterone levels in 98% of patients to levels comparable to surgical orchidectomy, achieving levels as low as 20 ng/dL.

This formulation offers a sustained release system that minimizes breakthrough testosterone levels and has a safety profile similar to other LHRH agonists, with mild side effects like hot flushes being the most common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a new leuprorelin formulation on testosterone levels in patients with advanced prostate cancer. Berges, R., Bello, U.[2013]

In the SPARTAN study, apalutamide combined with androgen deprivation therapy (ADT) led to rapid and significant reductions in prostate-specific antigen (PSA) levels in most patients, with 90% achieving at least a 50% reduction by 6 months, compared to only 1.5% in the placebo group.

Deep PSA responses (≥90% reduction or PSA ≤0.2 ng/ml) at 6 months were strongly linked to improved outcomes, including metastasis-free survival and overall survival, indicating that early PSA monitoring can be a valuable prognostic tool for patients with high-risk nonmetastatic castration-resistant prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Prostate-specific Antigen Response following Addition of Apalutamide to Ongoing Androgen Deprivation Therapy and Long-term Clinical Benefit in SPARTAN. Saad, F., Small, EJ., Feng, FY., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4107255/

Efficacy and tolerability of 1- and 3-month leuprorelin ... In this study, median total serum PSA and testosterone levels had decreased by 94% (from 11.6 ng/ml to 0.7 ng/ml) and 89% (from 89 ng/dl to 10 ng/dl) 6 months ...

2. eligardhcp.com eligardhcp.com/proven-efficacy-safety/

Efficacy in Prostate Cancer A single event reported as moderate pain resolved within 2 minutes and all 3 mild pain events resolved within several days following injection ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e17000

Real world data of leuprorelin castration efficacy in patients ... A total of 80 pts received combined treatment with leuprorelin + NHA, of which the majority received abiraterone/prednisone (n=52; 65%) or ...

4. openurologyandnephrologyjournal.com openurologyandnephrologyjournal.com/VOLUME/17/ELOCATOR/e1874303X237036/FULLTEXT/

6-month Formulations of Androgen Deprivation Therapy for ... A recent analysis found a high non-adherence rate of 84% for LHRH agonist injections based on dosing schedules used in pivotal trials. Method:.

5. urotoday.com urotoday.com/conference-highlights/esmo-2024/esmo-2024-prostate-cancer/154894-esmo-2024-prostate-cancer-efficacy-results-from-a-randomized-phase-3-evaluation-of-transdermal-estradiol-versus-lhrh-agonists-for-androgen-suppression-in-m0-prostate-cancer.html

ESMO 2024: Prostate Cancer Efficacy Results from a ... Transdermal estradiol lowers testosterone more rapidly, maintains bone mineral density, and improves metabolic outcomes and quality of life.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8899139/

ELIGANT: a Phase 4, interventional, safety study of ... The results of the ELIGANT study demonstrate that ELIGARD® 22.5 mg has an acceptable safety profile in men with hormone-dependent prostate cancer in Asia. There ...

7. cancerbiomed.org cancerbiomed.org/content/21/11/1012

Luteinizing hormone-releasing hormone receptor agonists ... LHRH-R agonists and antagonists, particularly goserelin, have demonstrated long-term survival benefits in patients with localized and locally advanced prostate ...

8. eligard.com eligard.com/about/

About ELIGARD ELIGARD causes an increase in testosterone during the first few weeks of therapy and some men may experience new or worsening symptoms of prostate cancer e.g., ...