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Adding Radiotherapy to Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer: A Phase II trial (AREnA trial)

Adding Radiotherapy to Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer: A Phase II trial (AREnA trial)

5

Sex [n (%)] Male: 5 subjects (100%) Age [mean (standard deviation, SD)] 73.8 (6.9) years old

First subject first visit: 07 October 2021 Study discontinuation: 05 September 2023 <Subject Disposition> Total enrolled (signed informed consent): 5 subjects Discontinued prior to expose study treatment: 0 subject

Adverse events: malaise [1], proctitis [1] Severe Adverse events: malaise [1, unrelated]

Not analyzed due to study discontinuation in 5 cases. No PSA progression was observed during the observation period in all four patients evaluated after the start of treatment, and PSA decreased by more than 90%. In one patient, progression at 36 weeks was observed on imaging (appearance of multiple metastases).

The results of this study suggest that the combination of enzalutamide and radiation therapy has an acceptable safety level and a certain degree of efficacy. However, there are limits to the interpretation of the results because it was evaluated in only five patients.

Mar. 01, 2024

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031210290

Yoshida Soichiro

Tokyo Medical and Dental University

1-5-45 Yushima, Bunkyo-ku, Tokyo

s-yoshida.uro@tmd.ac.jp

Yoshida Soichiro

Tokyo Medical and Dental University

1-5-45 Yushima, Bunkyo-ku, Tokyo

+81-3-5803-5295

s-yoshida.uro@tmd.ac.jp

Complete

Sept. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients with all of the following conditions will be eligible
1. 20 years of age or older and able to provide informed consent.
2. histologically or cytologically confirmed prostate cancer, without neuroendocrine, signet ring cell or small cell carcinoma
3. androgen deprivation therapy with GnRH agonist/antagonist or previous bilateral orchiectomy (drug or surgical castration) during the study period
4. testosterone level of less than 50 ng/dL at screening
5, patients with progressive disease who are on androgen deprivation therapy at the time of inclusion (disease progression is defined as three or more PSA increases at intervals of at least one week)
6, patients with a recent PSA level of 2 ng/mL or higher
7, PSA doubling time is less than 10 months
8. patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. patients expected to survive for at least 1 year
10. patients with prostate and/or pelvic lymph node involvement confirmed by CT, MRI or bone scintigraphy performed as routine care within 3 months (prostate lesions are confirmed by MRI)
11. patients who are willing and able to follow the study protocol, including follow-up visits and examinations.

A person is ineligible if he meets any of the following criteria.
1. patients who have received cytotoxic chemotherapy, aminoglutethimide, ketoconazole, olaparib, abiraterone acetate or enzalutamide for the treatment of prostate cancer
2. patients who have used the study drug within 4 weeks of the study start date
3. patients with a history of invasive cancer other than prostate cancer within 3 years of the study start date
4. patients with bone metastasis, visceral metastasis or distant lymph node metastasis confirmed by CT, MRI or bone scintigraphy performed as routine medical care within 3 months
5. neutrophil count less than 1,000,000/L, platelet count less than 100 x 1000,000,000/L and hemoglobin less than 10g/dL at screening
6. patients with total bilirubin more than 1.5 times the upper limit of normal (ULN), ALT and AST more than 2.5 times ULN at screening
7, patients with creatinine greater than 2 mg/dL at screening.
8, patients with albumin less than 3.0 g/dL at screening.
9, patients with a history of convulsive seizures or conditions that precipitate convulsive seizures.
10, patients with clinically significant cardiovascular disease.
11, patients with gastrointestinal diseases that affect absorption
12, patients who have undergone major surgery within 4 weeks of the study start date.
13. patients with hypersensitivity to the pharmaceutical ingredients, including labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
14. patients with conditions or circumstances that, in the judgment of the investigator, would place the patient at undue risk, interfere with the completion of the study, or interfere with the analysis of the study results
15, patients with a history of prior irradiation of the intended target therapy site.

Male

Prostatic Neoplasms, Castration-Resistant

Enzalutamide and targeted radiotherapy

Androgen Receptor Antagonists, radiotherapy

D064129

D059002, D011878

PSA-progression free survival

Failure-free survival
Time to radiological progression
Changes in PSA
Change in QOL

+81-3-5803-4575

July. 16, 2021

none