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

ConditionsNeoadjuvant TherapyHigh Risk Prostate CancerLocally Advanced Prostate CancerIntense Endocrine Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.

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).

Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.

Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.

Disqualifiers

Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.

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.

Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.

Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Treatment groups

900 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: ADT alone + prostatectomyActive comparator 2 interventions
Group B: ADT plus AbirateroneExperimental treatment 4 interventions
Group C: ADT plus EnzalutamideExperimental treatment 3 interventions
Group D: ADT plus ApalutamideExperimental treatment 3 interventions
Group E: ADT plus DarotamideExperimental treatment 3 interventions
Group F: ADT plus RizvilutamideExperimental treatment 3 interventions
Group G: PARP inhibitor + abiraterone + ADTExperimental treatment 5 interventions
Group H: PARP inhibitor + ADTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathologic response rate

Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate

Time frame
up to 3 years
2

3 year biochemical progression free survival (bPFS)

Biochemical progression free survival (bPFS) within 3 years

Time frame
up to 3 years

Secondary outcomes

1

Metastasis-Free Survival (MFS)

Metastasis-Free Survival (MFS) after intense neoadjuvant therapy

Time frame
up to 5 years
2

Time to castration-resistant prostate cancer（CRPC)

Time to castration-resistant prostate cancer（CRPC) after intense neoadjuvant therapy

Time frame
up to 5 years
3

PSA response rate

Prostate specific antigen (PSA) drops ≥ 98% after intense neoadjuvant therapy

Time frame
up to 3 years
4

Positive margin rate

The positive margin rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy

Time frame
up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov
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