A Randomized Controlled Trial Comparing Salvage Radiotherapy and Enzalutamide in Patients with High-risk Biochemical Recurrence or PSA Persistence after Radical Prostatectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0012360

Enrollment

130

Registered

2026-07-30

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Screening will be performed for patients with high-risk biochemical recurrence (PSADT =12 months) or persistent PSA (=0.1 ng/mL) following radical prostatectomy who have provided written inform

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: High-risk prostate cancer patients following radical prostatectomy who meet at least one of the following criteria: Biochemical Recurrence (BCR): prostate-specific antigen levels that reached undetectable levels (<0.1 ng/mL) and subsequently increased to =0.2 ng/mL on two consecutive measurements, with a prostate-specific antigen doubling time (PSADT) of =12 months. Prostate-specific antigen Persistence(PSA Persistence): Persistent PSA level of =0.1 ng/mL at 6 to 8 weeks post-operatively. Patients with no evidence of distant metastasis (M1) or pelvic local recurrence on standard imaging modalities (CT, Bone scan, MRI) (M0). Adult males aged 19 years or older. Eastern Cooperative Oncology Group (ECOG): performance status of 0 or 1. Patients who had a cumulative duration of prior androgen deprivation therapy (ADT) of =36 months, with at least 9 months elapsed since the last dose, and demonstrated recovery of serum testosterone levels (=150 ng/dL). Patients with adequate bone marrow, hepatic, and renal functions defined as follows: Absolute Neutrophil Count (ANC) = 1,500/µL, Platelets = 100,000/µL, Hemoglobin = 9.0 g/dL Total Bilirubin = 1.5 × Upper Limit of Normal (ULN) AST/ALT = 2.5 × ULN Serum Creatinine = 1.5 × ULN or Creatinine Clearance = 60 mL/min Patients who fully understand the purpose and details of the study and voluntarily provide written informed consent.

Exclusion criteria

Exclusion criteria: -Patients with radiologically confirmed distant metastasis or local mass other than residual cancer. -Patients with a history of prior salvage or adjuvant radiation therapy (RT) for prostate cancer. -Patients with a history of prior treatment with novel androgen receptor-targeted agents (e.g., Enzalutamide, Apalutamide, Darolutamide, Abiraterone, etc.). -Patients with contraindications to radiation therapy (e.g., active inflammatory bowel disease [IBD], history of prior pelvic radiation, etc.). -Patients with a history of seizure or underlying conditions predisposing to seizure (e.g., brain injury, stroke, epilepsy, etc.). -Patients with clinically significant cardiovascular disease (e.g., myocardial infarction within the past 6 months, unstable angina, congestive heart failure, etc.). -Patients with a history of other malignant tumors that may affect the efficacy and safety evaluation of this study (excluding basal cell carcinoma of the skin without recurrence within the past 5 years, etc.). -Patients deemed unsuitable for study participation by the principal investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Biochemical Recurrence-Free Survival (BRFS)	—

Secondary

Measure	Time frame
Prostate-specific antigen nadir;metastasis-free survival;Rate of deep response (Prostate-specific antigen < 0.02 ng/mL) at 9 months of treatment;Patient-reported quality of life (EPIC-26);Time to testosterone recovery after completion of treatment	—

Countries

Korea, Republic of

Contacts

Public ContactSe Young Choi

Chung-Ang University

alse3025@hanmail.net+82-2-6299-1810

Outcome results