Intense hormone therapy before surgery for advanced prostate cancer

A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

This study is testing whether a stronger hormone treatment before surgery can help men with advanced prostate cancer do better than the usual hormone therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05406999 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of neoadjuvant intense endocrine therapy in patients with high-risk or locally advanced prostate cancer. It involves a multicenter, multi-arm, non-randomized, open-label design where patients receive various forms of androgen deprivation therapy (ADT) prior to undergoing prostatectomy. The study aims to compare the outcomes of these therapies against standard ADT alone, focusing on improving treatment efficacy before surgical intervention.

Who should consider this trial

Good fit: Ideal candidates include men diagnosed with high-risk or locally advanced prostate cancer who are eligible for radical prostatectomy.

Not a fit: Patients with low-risk prostate cancer or those not eligible for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with high-risk prostate cancer by potentially reducing tumor size and improving surgical results.

How similar studies have performed: Other studies have shown promising results with neoadjuvant therapies in prostate cancer, indicating potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University — Nanjing, Jiangsu, China (Recruiting)

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