Platinum and Taxane Chemo for Prostate Cancer

(OPTION-DDR Trial)

Recruiting at 10 trial locations

Overseen By Mariam Jafri

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Must be taking: ARPI

Must not be taking: Platinum chemotherapy

Disqualifiers: Symptomatic brain metastasis, Uncontrolled illness, 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: 18

Duration: Until disease progression

236 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding carboplatin (a type of chemotherapy) to the usual prostate cancer treatment, which includes docetaxel (another chemotherapy drug), can help prevent cancer growth or spread. The goal is to determine if this new combination is more effective than the usual treatment alone. Men with prostate cancer who have already received hormone therapies like abiraterone or enzalutamide and are experiencing cancer progression might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

The trial requires a 'washout period' (time without taking certain medications) for some treatments, which is the longest of two weeks, 5 half-lives for investigational agents, or the standard cycle length of standard therapies. You should discuss your specific medications with the trial team to see if they need to be stopped.

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

Research has shown that the combination of carboplatin and docetaxel has been studied for safety in treating prostate cancer. A detailed review examined the safety of this combination for prostate cancer unresponsive to hormone therapy. The results suggest that while this combination can enhance treatment efficacy, patients may experience side effects such as low blood cell counts, fatigue, and nausea.

In another study, adding carboplatin to docetaxel improved treatment outcomes in patients with certain genetic traits, but they reported similar side effects. These side effects are common with many chemotherapy drugs and can usually be managed.

Since this trial is in a later phase, the treatment has already passed earlier safety tests, providing some reassurance about its safety in humans. However, discussing potential risks and benefits with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about the combination of Carboplatin and Docetaxel for treating prostate cancer because it offers a fresh approach compared to traditional treatments like androgen deprivation therapy (ADT) and chemotherapy with just Docetaxel. This combination leverages Carboplatin, a platinum-based drug, which may enhance the effectiveness of Docetaxel by targeting cancer cells in a new way. Unlike standard treatments that focus on hormone manipulation, this regimen could potentially overcome resistance and improve outcomes by directly attacking the cancer cells. This dual approach aims to provide a more robust treatment option for patients, with the hope of improved survival rates and better management of advanced prostate cancer.

What evidence suggests that adding Carboplatin to Docetaxel could be effective for prostate cancer?

Research has shown that adding carboplatin to docetaxel can improve outcomes for prostate cancer patients. In this trial, one group will receive the combination of carboplatin and docetaxel, while another group will receive only docetaxel. A review of several clinical trials has found that the combination effectively manages castration-resistant prostate cancer, which no longer responds to hormonal therapy. One study found that this combination significantly improved response rates in patients with a specific genetic condition affecting their cancer. Another study reported that patients receiving this combination lived for a median of 16 months. These findings suggest that using carboplatin with docetaxel might be more effective than using just docetaxel alone for treating certain prostate cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Kolinsky

Principal Investigator

Cross Cancer Institute, Edmonton, Alberta, Canada

Are You a Good Fit for This Trial?

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They must have had prior treatment with drugs like abiraterone or enzalutamide, no small cell carcinoma presence, and be past major surgeries by at least 28 days. Men can't join if they've taken investigational agents recently or have certain types of neuroendocrine tumors.

Inclusion Criteria

My cancer has spread, confirmed by scans within the last 28 days.

My prostate cancer is adenocarcinoma without any neuroendocrine or small cell features.

I have been treated with medications like abiraterone or enzalutamide before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either docetaxel or carboplatin in addition to docetaxel, with monitoring by CT scans and bone scans every 9 weeks, and blood tests every 3 weeks

Until disease progression

CT scans and bone scans every 9 weeks, blood tests every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with continued scans and tests until disease progression, and phone contact every 3 months for life

5.25 years

CT scans and bone scans every 9 weeks, blood tests every 3 weeks, phone contact every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Docetaxel

Trial Overview The study tests whether adding Carboplatin to the usual Docetaxel chemotherapy lowers the chance of prostate cancer growing or spreading. It compares this combination against the standard treatment alone to see which is more effective in controlling the disease.

How Is the Trial Designed?

Group I: Carboplatin + Docetaxel Experimental Treatment 2 Interventions

Group II: Docetaxel Active Control 1 Intervention

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

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 310 patients with castration-resistant prostate cancer (CRPC), the combination of taxane-estramustine-carboplatin (TEC) chemotherapy resulted in a significant prostate-specific antigen (PSA) response rate of 69%.

The 12-month survival estimate for patients receiving TEC chemotherapy was 79%, which is notably higher than the median predicted survival of 59%, indicating that TEC may provide substantial clinical benefits in CRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of carboplatin-taxane combinations in the management of castration-resistant prostate cancer: a pooled analysis of seven prospective clinical trials. Regan, MM., O'Donnell, EK., Kelly, WK., et al.[2021]

Docetaxel shows a 42% response rate in treating androgen-independent prostate cancer based on four Phase II studies, indicating its significant efficacy as a single-agent therapy.

Combining docetaxel with estramustine may enhance response rates but also increases toxicity, and ongoing Phase III studies are expected to clarify the best use of docetaxel in treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (taxotere) in the treatment of prostate cancer. Beer, TM., El-Geneidi, M., Eilers, KM.[2018]

Docetaxel-based therapy has been shown to provide a survival benefit for men with metastatic prostate cancer, marking a significant advancement beyond palliative care options.

Ongoing trials are exploring various combination therapies with docetaxel, but the best timing for initiating treatment remains unclear due to a lack of prospective clinical trial data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current role of chemotherapy in metastatic hormone-refractory prostate cancer. Petrylak, DP.[2022]

Recent reviews indicate that platinum-based chemotherapy, particularly carboplatin, can be effective in treating metastatic hormone-refractory prostate cancer (HRPC), especially when combined with other agents like taxanes and estramustine.

Next-generation platinum drugs, such as satraplatin, show promise in improving progression-free survival in HRPC patients, suggesting a potential new avenue for treatment, particularly for those who have progressed after standard docetaxel therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for platinum chemotherapy in the treatment of patients with hormone-refractory prostate cancer? Oh, WK., Tay, MH., Huang, J.[2007]

In a study of 15 patients with metastatic castration-resistant prostate cancer (mCRPC), docetaxel combined with carboplatin showed promising short-term efficacy, with 66.7% of patients experiencing a PSA decline of over 50%.

The treatment was generally well-tolerated, with most adverse reactions, such as bone marrow suppression and gastrointestinal issues, being manageable, indicating a favorable safety profile for this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of docetaxel combined with carboplatin in patients with metastatic castration-resistant prostate cancer]. Bai, GC., Song, Y., Jin, J., et al.[2022]

Carboplatin and paclitaxel (CP) demonstrated moderate efficacy in treating castration-resistant prostate cancer (CRPC), particularly as a first-line treatment, with a 55.6% PSA response rate and a median overall survival of 19 months for patients receiving it first.

In contrast, CP showed limited effectiveness in the third-line setting, with only a 10% PSA response rate and a median overall survival of 6 months, suggesting it may be more beneficial for patients with specific genetic mutations, like BRCA2 defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Carboplatin Plus Paclitaxel as the First-, Second-, and Third-line Chemotherapy in Men With Castration-resistant Prostate Cancer. Fujiwara, M., Akamatsu, S., Sumiyoshi, T., et al.[2020]

Docetaxel, an FDA-approved chemotherapy for various cancers, can cause severe side effects, including life-threatening reactions such as anaphylaxis and cardiac-respiratory arrest, as demonstrated in a case involving a 62-year-old patient with metastatic prostate cancer.

Despite premedication with corticosteroids, the patient experienced a cardiac-respiratory arrest within 15 minutes of receiving docetaxel, highlighting the need for careful monitoring during treatment, especially in patients with pre-existing conditions like atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation. Huq, M., Balvanz, TM., Mambourg, S.[2019]

Docetaxel-based treatments have shown effectiveness in managing advanced, androgen-independent prostate cancer, achieving significant palliative responses and reducing PSA levels by over 50% in patients.

Ongoing phase III trials are expected to provide crucial data on the impact of docetaxel on overall survival, while preliminary studies suggest that combining docetaxel with other novel agents is safe and may enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel in the integrated management of prostate cancer. Current applications and future promise. Logothetis, CJ.[2018]

In a pilot study of 15 patients with hormone-refractory prostate cancer resistant to paclitaxel-based chemotherapy, docetaxel (DTX) showed activity, with 33.3% of patients experiencing a 50% or greater reduction in prostate-specific antigen levels.

Despite its effectiveness, DTX treatment was associated with significant toxicities, including severe anemia in 66.7% of patients, highlighting the need for further research to optimize treatment regimens and manage side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel-based chemotherapy as second-line treatment for paclitaxel-based chemotherapy-resistant hormone-refractory prostate cancer: a pilot study. Urakami, S., Yoshino, T., Kikuno, N., et al.[2018]

In a study of 25 patients with advanced androgen-independent prostate cancer, docetaxel at a higher dose of 100 mg/m showed a 52% overall PSA response rate, with 60% of patients experiencing pain relief.

Despite its efficacy, the treatment had a significant toxicity profile, including severe neutropenia in 76% of patients, indicating that while docetaxel is effective, its use should be cautious and not routine due to the high risk of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of higher dose docetaxel in androgen-independent prostate cancer. Laber, DA., Glisson, SD., Hargis, JB., et al.[2018]

In a study involving 10 patients with hormone-refractory prostate cancer, weekly docetaxel-based chemotherapy showed a significant reduction in serum prostate-specific antigen (PSA) levels, with 90% of patients experiencing a decrease of 50% or more.

Weekly docetaxel-based chemotherapy was found to be as effective as triweekly chemotherapy while demonstrating lower toxicity, making it a suitable first-line treatment option for elderly patients or those with poor health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination chemotherapy with weekly paclitaxel or docetaxel, carboplatin, and estramustine for hormone-refractory prostate cancer. Yasufuku, T., Shigemura, K., Matsumoto, O., et al.[2018]

Docetaxel is the first treatment to significantly improve survival rates in patients with hormone-refractory prostate cancer, and it is now being tested in earlier stages of the disease to prevent recurrence in high-risk patients.

Pilot studies indicate that using docetaxel as a neo-adjuvant treatment can be done safely without increasing surgical risks, and ongoing randomized trials will further assess its effectiveness when combined with hormonal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-risk localized prostate cancer: integrating chemotherapy. Oh, WK.[2018]

Citations

1. nature.com nature.com/articles/s41598-025-04667-0

Impact of adding carboplatin to docetaxel chemotherapy on ... The median overall survival (OS) was 16 months (95% CI 13–20). Only two randomized trials (GETUG-AFU 15, RECARDO) have reported the outcomes of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7249847/

Efficacy of docetaxel combined carboplatin for the ... This systematic review and meta-analysis will explore the efficacy and safety of DC for the treatment of patients with CRPC.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)38756-3/fulltext

a pooled analysis of seven prospective clinical trials Efficacy of carboplatin–taxane combinations in the management of castration-resistant prostate cancer: a pooled analysis of seven prospective clinical trials.

4. asco.org asco.org/abstracts-presentations/ABSTRACT77970

Impact of carboplatin plus weekly docetaxel as salvage ... Background: Recent data suggest that carboplatin may be effective in combination with docetaxel in DRPC.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.5054

Final results of a pilot study of docetaxel and carboplatin for ... Conclusions: The addition of carboplatin to docetaxel significantly improved response rates in patients with mCRPC with biallelic inactivation ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00134706

A Study of Docetaxel Plus Carboplatin in Patients With ... The purpose of this study is to look at the effects (good and bad) of the combination of docetaxel and carboplatin for patients who have progressive prostate ...

7. cancerdiagnosisprognosis.org cancerdiagnosisprognosis.org/storage/cdp/1/5/cdp-1-451.pdf

cdp-1-451.pdf Median overall survival was 11 months, prostate-specific antigen progression-free survival was 6.5 months, and radiographic progression-free survival was 7 ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14575-1

Assessing the clinical outcomes of immunotherapy and ... Assessing the clinical outcomes of immunotherapy and docetaxel combinations in metastatic castration-resistant prostate cancer: a meta-analysis.