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

JRCT ID: jRCTs031210290

Registered date:01/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostatic Neoplasms, Castration-Resistant
• Date of first enrollment: 07/10/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Enzalutamide and targeted radiotherapy

Outcome(s)

• Primary Outcome: PSA-progression free survival

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Yoshida Soichiro
• Secondary Sponsor: Fujii Yasuhisa
• Source(s) of Monetary Support: Astellas Pharma Inc.