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

Plain-language summary

This study evaluates intense hormonal (endocrine) therapy given before surgery in patients with high-risk, locally advanced prostate cancer who are eligible for radical prostatectomy. The treatment uses androgen deprivation therapy (ADT), drugs such as Abiraterone Acetate and Enzalutamide, and in some patients a PARP inhibitor. The study is in Phase 2 and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Intervention

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

Start date

2/1/2020

Estimated completion

6/30/2030

Countries

China

Related genes

Locations

• Nanjing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.