Antiandrogen + Radiation +/- Docetaxel for Prostate Cancer

Not currently recruiting at 363 trial locations

Overseen By Mark Hurwitz, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: NRG Oncology

Must be taking: Antiandrogens

Must not be taking: Intravenous antibiotics

Disqualifiers: Metastatic disease, Prior chemotherapy, 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: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different treatments for prostate cancer after surgery. It compares two groups: one receiving antiandrogen therapy (which reduces male hormones that can promote cancer growth) and radiation, and the other receiving these treatments plus chemotherapy with docetaxel. Researchers aim to determine if adding docetaxel helps eliminate any remaining cancer cells. Men who have had prostate surgery within the last year and have a specific prostate cancer profile might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that finasteride or dutasteride must be stopped before treatment. It's best to discuss your specific medications with the trial team.

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

Research has shown that docetaxel, one of the treatments under study, has been used by many patients with prostate cancer. In one study, about 34% of patients who took docetaxel required hospital care, and some experienced febrile neutropenia, a fever due to low white blood cell counts. This side effect can be serious but is manageable with proper medical care.

In contrast, antiandrogen therapy, another treatment in the study, has already received FDA approval for prostate cancer. Patients generally tolerate it well. Common side effects might include fatigue or hot flashes, but these are usually mild.

Overall, while both treatments can cause side effects, they have been used in many patients and have established safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer a potential new weapon in the fight against the disease. Unlike standard treatments that primarily focus on hormone therapy and radiation, this approach adds docetaxel, a chemotherapy drug, to the mix. This is significant because docetaxel works by interfering with cancer cell division, potentially enhancing the effectiveness of hormone therapy and radiation. By combining these therapies, the treatment aims to tackle cancer more aggressively and could improve outcomes for patients with advanced prostate cancer.

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

Studies have shown that adding docetaxel to standard treatment can significantly lower the risk of death in men with aggressive prostate cancer. In this trial, some participants will receive androgen deprivation therapy and external beam radiation therapy (EBRT), while others will receive the same treatment with the addition of docetaxel. Research from the CHAARTED and STAMPEDE studies highlights a clear increase in overall survival for patients using docetaxel. Antiandrogen therapy, which reduces male hormones that help cancer grow, is a well-known treatment for prostate cancer and is often used with radiation to shrink or destroy tumors. Combining these treatments aims to target cancer cells more effectively after surgery. Early findings suggest this combination could lead to better outcomes for prostate cancer patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Mark D Hurwitz

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

Men with prostate cancer removed by surgery, no lymph node involvement or distant metastases, and a Gleason score >=7. They must have had the surgery within the last year, not received certain prior treatments for prostate cancer, and meet specific health criteria like blood counts and liver function tests.

Inclusion Criteria

I had surgery to remove my prostate gland.

I have undergone surgery to remove my prostate.

I've had a CT or MRI scan of my abdomen/pelvis in the last 120 days without signs of metastatic lymph nodes.

Exclusion Criteria

I have a history of inflammatory bowel disease.

Severe and/or active co-morbidity defined as follows:

I am currently on IV antibiotics for a bacterial or fungal infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Deprivation Therapy

Participants receive androgen deprivation therapy for 6 months

6 months

Regular visits as per treatment protocol

Radiation Therapy

Participants receive external beam radiation therapy (EBRT) for 7.5 weeks

7.5 weeks

Daily visits for radiation sessions

Chemotherapy (Docetaxel)

Participants receive docetaxel intravenously every 21 days for 6 cycles

18 weeks

6 visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 9 years

Every 3 months for 2 years, then every 6 months for 3 years, then yearly

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• External Beam Radiation Therapy
• Flutamide
• Goserelin Acetate
• Nilutamide

Trial Overview The trial is testing if adding docetaxel to antiandrogen therapy and radiation improves outcomes in post-surgery prostate cancer patients compared to just antiandrogen therapy and radiation. It's a randomized study meaning participants are put into groups by chance.

How Is the Trial Designed?

Group I: Arm II (androgen deprivation therapy, EBRT, docetaxel) Experimental Treatment 11 Interventions

Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV over 1 hour on day 1 of every 21 days for 6 cycless in the absence of disease progression or unexpected toxicity.

Group II: Arm I (androgen deprivation therapy, EBRT) Active Control 10 Interventions

Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.

External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in United States as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a Phase I study involving 18 patients with high-risk prostate cancer, the addition of weekly docetaxel chemotherapy at a safe dose of 20 mg/m² to high-dose intensity-modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) was found to be safe, with no severe toxicities reported.

At a median follow-up of 2.2 years, the treatment resulted in a high biochemical progression-free survival rate of 94%, indicating promising efficacy for this triple-therapy regimen in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of concurrent weekly docetaxel, high-dose intensity-modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for high-risk prostate cancer. Chen, RC., Rosenman, JG., Hoffman, LG., et al.[2019]

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]

In a multicenter phase 2 trial involving 61 intermediate-risk prostate cancer patients, the combination of external beam radiation therapy (EBRT) and transperineal prostate brachytherapy with androgen deprivation therapy (ADT) resulted in a high six-year disease-free survival (DFS) rate of 87.1%.

The treatment was associated with acceptable late toxicity, with only 20% of patients experiencing late grade 2 toxicity and 3% experiencing grade 3 toxicity, indicating a favorable safety profile for this combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination external beam radiation and brachytherapy boost with androgen deprivation for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. Hurwitz, MD., Halabi, S., Archer, L., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40276087/

Real‑world data on the outcomes of upfront docetaxel in ... The present study demonstrated that upfront docetaxel chemotherapy may be an effective and tolerable treatment for hormone-sensitive metastatic ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811171

Mortality Risk for Docetaxel-Treated, High-Grade Prostate ... Adding docetaxel to SOC treatment in patients who were in otherwise good health was associated with a significant reduction in death due to prostate cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225005103

Article Real-world effectiveness of novel hormonal agents ... Article. Real-world effectiveness of novel hormonal agents and docetaxel in patients with prostate cancer: a head-to-head comparison.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5424862/

Docetaxel in prostate cancer: a familiar face as the new ... In the CHAARTED and STAMPEDE studies, docetaxel provides an unprecedented increase in overall survival (OS). This review summarizes the evidence behind the ...

5. 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28940952/

Real-world uptake, safety profile and outcomes of ... Results: Of the 270 eligible patients, 103 received docetaxel (38.1%). 35 patients (34%) were hospitalised and there were 17 episodes of febrile neutropenia ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00242918

Safety and Effectiveness Study of Docetaxel and ZD1839 ... The critical issue is in addressing micrometastatic disease that has already developed prior to diagnosis. This study utilizes daily doses of ZD1839 and weekly ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01283

The Randomized, Double-Blind, Phase III KEYNOTE-921 ... Among participants with PD-L1–positive mCRPC, median OS was 19.8 months (95% CI, 16.2 to 22.0) in the pembrolizumab plus docetaxel group versus ...