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Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
This study will assess the effects and safety of deutenzalutamide combined with hormone therapy before and after prostate cancer surgery, with docetaxel chemotherapy added before surgery. It is intended for men with high-risk localized or locally advanced prostate cancer who have no distant spread on imaging and are suitable for surgery. The researchers will measure how often treatment leaves no cancer or only a very small amount of cancer in the prostate, with no cancer in the pelvic lymph nodes removed during surgery. They will also assess whether participants can undergo the planned surgery, what side effects occur, and whether the cancer returns or spreads during follow-up. Up to 37 participants will be enrolled at several hospitals. All participants will be assigned to the same treatment plan; there is no comparison group. The planned treatment includes: * Deutenzalutamide taken by mouth each day, together with hormone therapy to lower testosterone levels, for 24 weeks before surgery. * Docetaxel given through a vein once every 3 weeks for six cycles during the treatment period before surgery. * Surgery to remove the prostate and pelvic lymph nodes, when medically appropriate. * A further 24 weeks of deutenzalutamide and hormone therapy after recovery from surgery, without further docetaxel. Hormone therapy will continue across the treatment periods for a total of at least 13 months. Treatment may be adjusted or stopped according to side effects and the participant's condition. Follow-up is planned for up to 5 years after all study treatment has ended. Participants may also choose to join an optional study using a single blood sample collected before treatment and leftover tissue from their diagnostic prostate biopsy. These samples will be used to explore features that may be associated with treatment response and later outcomes. Participation in this optional component is not required to receive the study treatment.
Official title: POST-PC-01: A Prospective, Multicenter, Single-Arm, Open-Label, Exploratory Study of Perioperative Deutenzalutamide Plus Androgen-Deprivation Therapy With the Addition of Docetaxel in the Neoadjuvant Phase in Patients With High-Risk Localized or Locally Advanced Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2026-11
Completion Date
2035-01
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Deutenzalutamide
Deutenzalutamide 80 mg is administered orally once daily with androgen deprivation therapy (ADT) for 24 weeks before radical prostatectomy. After adequate postoperative recovery, deutenzalutamide is planned to resume approximately 4 weeks after surgery at the last tolerated dose, with ADT, for an additional 24 weeks. Dose modifications and treatment interruptions are managed according to the protocol.
Docetaxel
Docetaxel 60 mg/m² is administered by intravenous infusion every 3 weeks for 6 cycles (planned at Weeks 0, 3, 6, 9, 12, and 15) during neoadjuvant treatment, in combination with deutenzalutamide and androgen deprivation therapy (ADT). Treatment interruptions and discontinuation follow protocol-defined criteria; docetaxel is not administered during postoperative adjuvant treatment.
ADT
Androgen deprivation therapy (ADT) is administered according to the prescribing information for the selected agent. Treatment begins in the neoadjuvant phase and continues through the perioperative and postoperative adjuvant phases for a total duration of at least 13 months.
Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China