Docetaxel + Degarelix for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Androgen deprivation therapy

Disqualifiers: CNS metastases, Active cardiac disease, others

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

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

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of combining two drugs, docetaxel (a chemotherapy drug) and degarelix (a hormone therapy), for treating prostate cancer, particularly when docetaxel is administered before hormone therapy. The trial targets patients with prostate cancer that has metastasized. Suitable candidates are those diagnosed with prostate cancer that has spread to areas like bones or organs and have not yet received extensive hormone or chemotherapy for this condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that combining docetaxel and degarelix for prostate cancer has been studied for safety. In one study with 50 patients, 12% experienced significant side effects, but none faced the most severe reactions. This suggests that while some patients may encounter notable side effects, the most severe reactions are rare.

For degarelix, research indicates it might pose a lower risk of heart problems compared to leuprolide. Over 12 months, degarelix had a 5.1% chance of causing heart-related issues, lower than leuprolide's 10.2%.

Overall, these treatments appear to be generally well-tolerated, with some risk of significant but not severe side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional hormone therapies for prostate cancer that often focus on continuous hormone suppression, the treatment combining Docetaxel and Degarelix employs a strategic timing method. Researchers are excited about this combination because Docetaxel, a chemotherapy drug, is paired with Degarelix, a GnRH receptor antagonist, to target cancer cells more aggressively. This sequence allows for more targeted hormone suppression during chemotherapy, potentially enhancing treatment effectiveness and minimizing side effects. This innovative approach may offer a more efficient way to manage advanced prostate cancer compared to existing options like continuous hormone therapy alone.

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

This trial will evaluate the combination of docetaxel and degarelix for treating prostate cancer. Studies have shown that using these drugs together can effectively treat prostate cancer. Research indicates that combining docetaxel with hormone therapy, such as degarelix, helps patients live longer. Specifically, adding docetaxel was linked to a 70% decrease in deaths caused by prostate cancer. This combination also significantly reduced inflammation markers, such as CRP and IL-6, which are associated with cancer progression. These findings suggest that this treatment could manage prostate cancer more effectively. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Men over 18 with newly diagnosed metastatic prostate cancer, who haven't had certain previous treatments for it. They should have a specific blood cell count, no brain or severe heart conditions, and not be HIV-positive. Participants must agree to use birth control during the trial and have an ECOG performance status of 0-2.

Inclusion Criteria

My vital organs are functioning well.

I agree to use barrier contraception during and for a month after my docetaxel treatment.

My prostate cancer is confirmed by lab tests.

Exclusion Criteria

I have been on anti-androgen therapy for more than 30 days before starting this study.

I haven't had cancer treatment in the last 5 years, except for skin cancer.

I've had over 3 years of hormone therapy with surgery or radiation for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive docetaxel for up to 6 cycles every 21 days, followed by degarelix starting from cycle 5

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PSA response and adverse events

10 months

Extension

Degarelix continues to be administered every 28 days for 5 more doses after the initial treatment phase

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Degarelix
• Docetaxel

Trial Overview The study is testing the effectiveness of starting treatment with Docetaxel before Degarelix in managing metastatic prostate cancer. It's a Phase II trial focusing on patient outcomes with this sequence of drug administration.

How Is the Trial Designed?

Group I: Docetaxel + Degarelix Experimental Treatment 2 Interventions

Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses.

Degarelix is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Firmagon for:

• Advanced hormone-dependent prostate cancer

Approved in United States as Firmagon for:

• Advanced prostate cancer

Approved in Canada as Firmagon for:

• Hormone-sensitive prostate cancer

Approved in Japan as Firmagon for:

• Prostate cancer

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.116

Preliminary results from a phase II trial of docetaxel before ... Background: Randomized trials have demonstrated a survival advantage to administering docetaxel (D) shortly after initiation of androgen ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35874639/

Effects of Docetaxel plus Degarelix on Quality of Life and ... Docetaxel plus degarelix resulted in significantly reduced levels of CRP and IL-6 and a significantly higher IL-10 level (28.84 ± 5.42, 25.31 ± ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1155/2022/9082501

Effects of Docetaxel plus Degarelix on Quality of Life and ... Docetaxel plus degarelix resulted in significantly reduced levels of CRP and IL-6 and a significantly higher IL-10 level (28.84 ± 5.42, 25.31 ± ...

4. brighamhealthonamission.org brighamhealthonamission.org/2023/11/06/docetaxel-found-to-be-significantly-associated-with-reduced-prostate-cancer-mortality-in-patients-with-otherwise-poor-prognosis/

Docetaxel Found to Be Significantly Associated With ... SOC plus docetaxel was associated with a significant 70% reduction in prostate cancer-specific mortality (PCSM) and a nearly halved all-cause mortality.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04633252

Study Details | NCT04633252 | M9241 in Combination ... Docetaxel has limited efficacy in metastatic castration resistant prostate cancer (mCRPC) patients who have already progressed on anti-androgen therapy ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056810

Cardiovascular Safety of Degarelix Versus Leuprolide in ... Over 12 months, primary outcome event rates were projected to be 5.1% for degarelix and 10.2% for leuprolide. Under this assumption, an ...

7. urotoday.com urotoday.com/conference-highlights/esmo-2023/esmo-2023-prostate-cancer/147615-esmo-2023-tolerance-and-long-term-side-effects.html

ESMO 2023: Tolerance and Long-Term Side-Effects Based on this data, Dr. Morgans concluded that ADT + ARPI can be well-tolerated by most patients and may improve quality of life versus ADT ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04126070

Nivolumab + Docetaxel + ADT in mHSPC Patients With ... The goal of this study is to examine the activity and safety of hormonal therapy combined with docetaxel chemotherapy and nivolumab immunotherapy for hormone ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11117159/

Survival after docetaxel for metastatic castration-resistant ... According to US SEER-Medicare data (2007–2019) median survival from the start of first-line treatment (docetaxel or other drugs) for MCRPC was 21.5 months [19].