Hormone Therapy Duration for Prostate Cancer

(PCS-XII Trial)

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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.

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.

What data supports the effectiveness of the treatment Eligard, Prostate SBRT or Prostate Brachytherapy with Radiation Therapy for prostate cancer?

Research suggests that early hormone therapy, like Eligard, may improve survival and delay disease progression in prostate cancer. Additionally, combining hormone therapy with radiation treatments, such as Prostate SBRT or Brachytherapy, is a common approach to enhance treatment effectiveness. ^{1 2 3 4 5}

Is hormone therapy with Eligard safe for humans?

Eligard, a hormone therapy for prostate cancer, has been shown to be generally safe in humans. Clinical studies have demonstrated its ability to effectively lower testosterone levels with a manageable safety profile, including a lower than expected incidence of severe hot flashes. ^{6 7 8 9 10}

How does the drug Eligard differ from other treatments for prostate cancer?

Eligard is unique because it uses a novel sustained-release delivery system for leuprolide acetate, allowing for reliable and prolonged suppression of testosterone levels with fewer severe hot flashes compared to other treatments. This subcutaneous injection is available in 1-month and 3-month formulations, with longer durations in development, offering flexibility in treatment scheduling. ^{7 8 11 12 13}

Research Team

Georges Wakil, MDCM, FRCPC, DABR

Principal Investigator

Hopital Charles Lemoyne

Tamim Niazi, MDCM, FRCPC

Principal Investigator

Jewish General Hospital

Eligibility Criteria

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

My recent scans show no cancer in my pelvic or para-aortic lymph nodes.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Selection criteria for initiation and renewal of luteinizing hormone-releasing hormone agonist therapy in patients with prostate cancer: a French prospective observational study. [2022]

2. Switzerland 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Conservative management with symptomatic treatment and delayed hormonal manipulation is justified in men with locally advanced carcinoma of the prostate. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Early versus deferred hormone therapy. [2018]

5. Japan pubmed.ncbi.nlm.nih.gov

Luteinizing hormone-releasing hormone agonist monotherapy for prostate cancer: outcome and prognostic factors. [2019]

6. China pubmed.ncbi.nlm.nih.gov

ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD®) in Asian men with prostate cancer. [2022]

7. Switzerland 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Eligard: leuprolide acetate in a novel sustained-release delivery system. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Effect of a new leuprorelin formulation on testosterone levels in patients with advanced prostate cancer. [2013]

10. England pubmed.ncbi.nlm.nih.gov

A 6-month depot formulation of leuprolide acetate is safe and effective in daily clinical practice: a non-interventional prospective study in 1273 patients. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Picking the optimal duration of hormonal therapy in men with high-risk and locally advanced prostate cancer treated with radiotherapy. [2013]

12. France pubmed.ncbi.nlm.nih.gov

[Interest of the radiotherapy-hormonotherapy association in the treatment of the high-risk prostate cancer]. [2009]

13. Italy pubmed.ncbi.nlm.nih.gov

[Neoadjuvant combined hormonal therapy and radiotherapy with external beam irradiation in prostatic carcinoma]. [2013]