Hormone Therapy + Radiation for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+567 other locations
Overseen ByNeil B Desai
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NRG Oncology
Must not be taking: Hormonal therapy, Anti-androgens
Disqualifiers: Metastatic disease, Prior malignancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.
Will I have to stop taking my current medications?
The trial requires that you stop taking any testosterone replacement therapy and 5-alpha-reductase inhibitors at least 30 days 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 drug Bicalutamide when used with radiation therapy for prostate cancer?
Research shows that using Bicalutamide (Casodex) 150 mg daily as an immediate treatment after radiotherapy significantly reduces the risk of prostate cancer progression by 37% compared to radiotherapy alone, indicating its effectiveness as an adjuvant therapy.
12345Is hormone therapy with bicalutamide safe for prostate cancer treatment?
Bicalutamide, used in prostate cancer treatment, is generally well tolerated, but common side effects include breast pain and gynecomastia (enlarged breast tissue in men). In a study, adverse reactions occurred in about 61-65% of patients, but the treatment was still considered safe and effective.
24678How does the drug combination of hormone therapy and radiation differ from other prostate cancer treatments?
This treatment combines hormone therapy with radiation, using drugs like bicalutamide (Casodex) to improve survival in high-risk prostate cancer patients. Unlike traditional castration therapies, bicalutamide offers a non-castration-based approach, potentially improving quality of life while effectively enhancing the effects of radiation therapy.
245910Eligibility Criteria
Men aged 18+ with unfavorable intermediate risk prostate cancer, specifically adenocarcinoma of the prostate, without prior treatments like radiotherapy or hormonal therapy to the pelvis. They must have a certain level of physical fitness (ECOG 0-2), adequate organ function, and no severe co-morbidities or high-risk features such as Gleason score 8-10 or metastatic disease.Inclusion Criteria
I have chronic hepatitis B but it's under control with medication.
My prostate cancer is at an intermediate stage but considered high risk.
My white blood cell count is healthy.
I am 18 years old or older.
My kidney function, measured by creatinine clearance, is adequate.
I had hepatitis C but have been successfully treated and cured.
Exclusion Criteria
I have had radiation therapy to my prostate or pelvis area before.
I have had both testicles surgically removed.
I have not had any other cancer besides this one in the last 3 years.
I have undergone hormonal therapy before.
I had surgery or targeted treatment to cure my prostate cancer.
My cancer has spread to other parts of my body.
I am currently on testosterone replacement therapy.
I cannot swallow pills.
Participant Groups
The trial is testing two approaches based on Decipher gene risk scores: less intense treatment (radiation alone) for low-risk patients versus more intense treatment (radiation plus hormone therapy and darolutamide) for higher-risk patients. Darolutamide blocks male hormones that can fuel cancer growth.
4Treatment groups
Experimental Treatment
Group I: Arm IV (RT, ADT, darolutamide)Experimental Treatment9 Interventions
Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm III (RT, ADT)Experimental Treatment10 Interventions
Patients receive treatment as in Arm II.
Group III: Arm II (RT, ADT)Experimental Treatment10 Interventions
Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days.
Group IV: Arm I (RT)Experimental Treatment1 Intervention
Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity.
Bicalutamide is already approved in European Union, United States, Japan, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇺🇸 Approved in United States as Casodex for:
- Metastatic prostate cancer
🇯🇵 Approved in Japan as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇨🇦 Approved in Canada as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇦🇺 Approved in Australia as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrooke, Canada
Brooke Army Medical CenterFort Sam Houston, TX
Torrance Memorial Medical CenterTorrance, CA
University of Kansas Hospital-Indian Creek CampusOverland Park, KS
More Trial Locations
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Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Immediate Treatment with Bicalutamide, 150 mg/d, Following Radiotherapy in Localized or Locally Advanced Prostate Cancer. [2020]Previous studies and meta-analyses have made it clear that some subgroups of prostate cancer patients who have received radiotherapy should benefit from immediate adjuvant hormonal therapy. A cohort totaling 1370 patients who received radiotherapy for early nonmetastatic prostate cancer is currently enrolled in three ongoing, randomized, double-blind, placebo-controlled trials investigating the role of bicalutamide ('Casodex') 150 mg/d as adjuvant to standard care (the bicalutamide Early Prostate Cancer program). At preliminary analysis, conducted after a median follow-up of 3 years, adjuvant therapy with bicalutamide 150 mg/d significantly reduced the risk of objective progression by 37% compared with radiotherapy alone (HR 0.63, 95% CI, 0.46-0.85, P = .0024). Initial results demonstrate that bicalutamide 150 mg/d given as immediate adjuvant therapy following radiotherapy in men with early nonmetastatic prostate cancer has benefits over radiotherapy alone.
A randomised comparison of bicalutamide ('Casodex') 150 mg versus placebo as immediate therapy either alone or as adjuvant to standard care for early non-metastatic prostate cancer. First report from the Scandinavian Prostatic Cancer Group Study No. 6. [2019]To assess the efficacy and tolerability of bicalutamide 150 mg ('Casodex'(1)) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with early (T1b-T4, any N, M0) prostate cancer.
Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression. [2019]To investigate the efficacy and tolerability of bicalutamide (Casodex) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with localized or locally advanced (T1b-T4, any nodal status, M0) prostate cancer.
Antagonistic interaction between bicalutamide (Casodex) and radiation in androgen-positive prostate cancer LNCaP cells. [2014]Bicalutamide (Casodex) reportedly improves high-risk prostate cancer survival as an adjuvant treatment following radiotherapy. However, biological data for the interaction between bicalutamide and ionizing radiation in concomitant association are lacking.
The biological basis for the use of an anti-androgen and a 5-alpha-reductase inhibitor in the treatment of recurrent prostate cancer: Case report and review. [2014]Although many prostate cancer cases relapse to a hormone-insensitive state, endocrine therapy involving androgen depletion by orchiectomy or by treatment with LHRH-analogue as well as blockade of the androgen receptor (AR) with anti-androgens remains a primary treatment option. Quality of life (QOL) however, is a prime consideration of men choosing such an approach. In this report we discuss a synergistic combination of 150-mg bicaltumide (Casodex) and 5 mg finasteride (Proscar) in the treatment of a 69-year-old patient with a relapsed (biochemical failure) Gleason score 7 prostate cancer, initially treated with external beam radiation therapy. A successful clinical outcome as evidenced by undetectable serum PSA, bone scan density and overall general well-being was accomplished with minimal side effects. Experiments using an established hormone-dependent prostate cancer cell line (LNCaP) showed that the combination of bicaltumide-finasteride at the same ratio as used clinically, produced synergistic effects on the inhibition of cell proliferation and AR expression/phosphorylation. A more complete inactivation of the AR on this regimen may have had the effect of constraining the ability of the AR to mutate, and/or diminishing the ability of androgen independent clones to evolve. Thus, passage to androgen independence may have been slowed or arrested.
[Clinical early phase II study of bicalutamide (Casodex) in patients with prostatic cancer]. [2015]To investigate the efficacy and safety of bicalutamide (Casodex) with its clinically recommended dose, the randomized early phase II study was performed in 124 patients with prostatic cancer (stage C, D). The patients were given 50, 80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks; 122 patients were eligible for evaluation. The overall response rate was 50.0% (20/40), 61.0% (25/41) and 53.7% (22/41) in the 50 mg, 80 mg and 100 mg groups, respectively. The response rate in prostate lesion, bone and lymph node metastases was slightly higher in the 80 mg group than in the 50 mg and 100 mg groups. The proportion of patients showing a response with regard to serum PSA (CR and PR) was 84.2, 92.7 and 97.6% in the 50, 80 and 100 mg groups, respectively. The incidence of adverse reactions was 65.0, 61.0 and 61.0% in the 50, 80 and 100 mg groups, respectively, and there was no significant difference in overall safety rating in the three groups. Frequent adverse reactions were gynecomastia and breast pain. Only one patient in the 80 mg group was withdrawn due to shortness of breath. Serum concentrations of LH, testosterone and estradiol increased significantly after treatment. Bicalutamide was concluded to be effective and well tolerated in patients with prostatic cancer, and its recommended dose was 80 mg once daily.
Is bicalutamide equivalent to goserelin for prostate volume reduction before radiation therapy? A prospective, observational study. [2019]We compare the cytoreductive efficacy of bicalutamide or goserelin with no hormonal manipulation in prostate cancer before brachytherapy.
[A new anti-androgen, bicalutamide (Casodex), for the treatment of prostate cancer--basic clinical aspects]. [2014]Bicalutamide (Casodex) has been approved as a new option for the treatment of prostate cancer. It is a new non-steroidal anti-androgen synthesized by the British company Zeneca. In pharmacological studies using rats and other subjects, the product showed excellent affinity with androgen receptors and was found to be anti-androgen active and effective against tumors, and so clinical trials have begun. Approval has been obtained in approximately 70 countries, including the United Kingdom, the United States and Germany. Anti-androgens are used extensively in combination with LHRH analogs or surgical castration (MAB therapy) in the treatment of prostate cancer. Overseas, encouraging results have been obtained from comparative trials using bicalutamide or flutamide in MAB therapy. Bicalutamide is expected to be highly effective. Moreover, it can be administered in a once-daily dose, which is expected to improve patient compliance. In a late Phase II study in Japan, a response rate as high as 64.4% was achieved when bicalutamide was administered alone. The potential for bicalutamide to be used alone is important because of the growing emphasis on patient quality of life and sexual function in prostate cancer therapy.
The addition of bicalutamide 150 mg to radiotherapy significantly improves overall survival in men with locally advanced prostate cancer. [2018]Castration therapy adjuvant to radiotherapy can significantly improve overall survival compared with radiotherapy alone in patients with locally advanced prostate cancer. Although many of the adverse effects of castration therapy are manageable, they can have a detrimental effect on quality of life. Here we evaluate the efficacy and tolerability of the non-castration-based therapy bicalutamide ('Casodex') 150 mg adjuvant to radiotherapy in patients with T1-4, M0, any n prostate cancer.
Risk of prostate cancer death after radical radiotherapy with neoadjuvant and adjuvant therapy with bicalutamide or gonadotropin-releasing hormone agonists. [2023]Label="BACKGROUND" NlmCategory="UNASSIGNED">Oncological outcome after radical radiotherapy (RRT) combined with neoadjuvant and adjuvant androgen suppression therapy (AST) may differ according to type of AST. The aim of this nationwide register-based study was to investigate risk of prostate cancer (Pca) death after different neoadjuvant and adjuvant ASTs; (i) bicalutamide, (ii) gonadotropin-releasing hormone agonists (GnRH) or (iii) combined bicalutamide and GnRH (CAB), together with RRT.