Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT05406999
Phase
PHASE2
Status
Recruiting
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Conditions

  • High Risk Prostate Cancer
  • Intense Endocrine Therapy
  • Locally Advanced Prostate Cancer
  • Neoadjuvant Therapy

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ADT — DRUG
    The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.
  • Abiraterone Acetate — DRUG
    1000 mg (250 mg×4 tablets) once daily, orally
  • Prednisolone tablets — DRUG
    5 mg once daily, orally.
  • Enzalutamide — DRUG
    160 mg (40 mg× 4 tablets) once daily, orally.
  • Apalutamide — DRUG
    240 mg (60 mg×4 tablets) once daily, orally.
  • Darotamide — DRUG
    600 mg (300 mg × 2 tablets) twice daily, orally.
  • Rezvilutamide — DRUG
    240 mg (80 mg × 3 tablets) once daily orally
  • PARP inhibitor — DRUG
    The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.
  • Robot-assisted radical prostatectomy — PROCEDURE
    Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Study Details

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

Key Dates

Start date
Feb 1, 2020
Status verified
Aug 2022
Primary completion
Dec 31, 2026
Completion
Jun 30, 2030

Study Design

Enrollment
900 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ADT alone + prostatectomy
    A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: ADT plus Abiraterone
    A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: ADT plus Enzalutamide
    A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: ADT plus Apalutamide
    A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: ADT plus Darotamide
    A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: ADT plus Rizvilutamide
    A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: PARP inhibitor + abiraterone + ADT
    A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
  • Experimental: PARP inhibitor + ADT
    A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Primary Outcome Measure

Pathologic response rate [ Time Frame: up to 3 years ]

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