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

N

Nanjing University

Status and phase

Enrolling
Phase 2

Conditions

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

Treatments

Procedure: Robot-assisted radical prostatectomy
Drug: Enzalutamide
Drug: Apalutamide
Drug: Abiraterone Acetate
Drug: ADT
Drug: Rezvilutamide
Drug: PARP inhibitor
Drug: Darotamide
Drug: Prednisolone tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT05406999
IUNU-PC-118

Details and patient eligibility

About

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.

Full description

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Enrollment

900 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
  2. All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
  3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
  4. Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
  5. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must bewilling to obey the prohibitions and restrictions specified in the research protocol.
  6. Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.

Exclusion criteria

  1. Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
  2. Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3; b) Gleason score of primary tumor < 8; c) prostate specific antigen (PSA) <20 ng/ml.
  3. Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.
  4. Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.
  5. Patients with severe or uncontrolled concurrent infections are not eligible.
  6. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
  7. Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
  8. Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
  9. Patients with mental illness, mental disability or inability to give informed consent are not eligible.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

900 participants in 8 patient groups

ADT alone + prostatectomy
Active Comparator group
Description:
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.
Treatment:
Procedure: Robot-assisted radical prostatectomy
Drug: ADT
ADT plus Abiraterone
Experimental group
Description:
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.
Treatment:
Procedure: Robot-assisted radical prostatectomy
Drug: Abiraterone Acetate
Drug: ADT
Drug: Prednisolone tablets
ADT plus Enzalutamide
Experimental group
Description:
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.
Treatment:
Procedure: Robot-assisted radical prostatectomy
Drug: Enzalutamide
Drug: ADT
ADT plus Apalutamide
Experimental group
Description:
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.
Treatment:
Procedure: Robot-assisted radical prostatectomy
Drug: ADT
Drug: Apalutamide
ADT plus Darotamide
Experimental group
Description:
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.
Treatment:
Procedure: Robot-assisted radical prostatectomy
Drug: Darotamide
Drug: ADT
ADT plus Rizvilutamide
Experimental group
Description:
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.
Treatment:
Drug: Rezvilutamide
Procedure: Robot-assisted radical prostatectomy
Drug: ADT
PARP inhibitor + abiraterone + ADT
Experimental group
Description:
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.
Treatment:
Drug: PARP inhibitor
Procedure: Robot-assisted radical prostatectomy
Drug: Abiraterone Acetate
Drug: ADT
Drug: Prednisolone tablets
PARP inhibitor + ADT
Experimental group
Description:
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.
Treatment:
Drug: PARP inhibitor
Procedure: Robot-assisted radical prostatectomy
Drug: ADT

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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