Antiandrogen + Radiation +/- Docetaxel for Prostate Cancer

Recruiting at 354 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

612 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment combining antiandrogens, radiation, and possibly docetaxel for prostate cancer?

Research shows that combining external beam radiation therapy (EBRT) with androgen deprivation therapy (ADT), such as goserelin acetate, improves long-term survival rates in prostate cancer patients. Additionally, clinical trials have demonstrated better outcomes when ADT is combined with radiotherapy, suggesting that these combinations may enhance treatment effectiveness. ^{1 2 3 4 5}

Is the combination of antiandrogens, radiation, and docetaxel safe for treating prostate cancer?

The combination of external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) has been widely used and studied for prostate cancer, showing long-term safety and effectiveness. Goserelin, a type of ADT, has been shown to improve survival rates when combined with radiation therapy. These treatments have been generally well-tolerated in clinical trials, although specific safety data for the addition of docetaxel in this combination is not detailed in the provided research. ^{2 5 6 7 8}

How does the Antiandrogen + Radiation +/- Docetaxel treatment for prostate cancer differ from other treatments?

This treatment is unique because it combines antiandrogen therapy (which blocks male hormones that fuel cancer growth) with radiation and may include docetaxel, a chemotherapy drug, to potentially improve outcomes for high-risk prostate cancer. The addition of docetaxel to modern radiation therapy has shown promising safety and effectiveness in early studies, offering a novel approach compared to standard treatments. ^{9 10 11 12 13}

What is the purpose of this trial?

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Research Team

Mark D Hurwitz

Principal Investigator

NRG Oncology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Beyond Just Androgen Deprivation Therapy: Novel Therapies Combined With Radiation. [2018]

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

Comparison of goserelin and leuprolide in combined androgen blockade therapy. [2022]

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

Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. [2021]

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

Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Goserelin acetate in combination with radiotherapy for prostate cancer. [2019]

6. United States 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. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Combined high dose rate brachytherapy and external beam radiotherapy for clinically localised prostate cancer. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Adjuvant goserelin improves clinical disease-free survival and reduces disease-related mortality in patients with locally advanced or localized prostate cancer. [2019]

9. England 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. [2019]

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

Combination of docetaxel, estramustine phosphate, and zoledronic acid in androgen-independent metastatic prostate cancer: efficacy, safety, and clinical benefit assessment. [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Prostate cancer: future strategies for chemotherapy management]. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Palliative systemic therapy of castration-resistant prostate cancer: current developments]. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Docetaxel (taxotere) in the treatment of prostate cancer. [2018]