CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

NCT06306612 | Recruiting

• 1 other identifier: IIT-2023-0165
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are:

1. 1.To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC.
2. 2.To explore the characteristics of the subgroup of patients who could benefit more from the above treatment.
3. 3.To explore the relationship between stage efficacy and clinical prognosis.
4. 4.To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Castration resistant-free survival

  From date of randomization to the date of the following events, whichever occurs first: prostate specific antigen (PSA) elevation above nadir of at least 2 ng/mL or elevation above nadir of at least 25% when testosterone is at castration level (\<50 ng/dL), as determined by reassessment at least 3 weeks later; or soft tissue, visceral, or radiographic progression of skeletal lesions: as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG)3, Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 is applied via magnetic resonance imaging (MRI) of the thorax/abdomen/pelvis to determine radiographic progression of soft tissue/visceral lesions; bone metastases are identified separately from soft tissue/visceral metastases and are determined by 99mTc methylenediphosphonate bone scanning of the whole body according to PCWG3. Metastases may also be identified using PSMA-PET/CT.

  Through study completion, assessed up to three years.

Secondary Outcomes (5)

• Overall Survival

  Through study completion, assessed up to three years.

• PSA response

  Through study completion, assessed up to three years.

• Symptomatic skeletal event

  Through study completion, assessed up to three years.

• Pain progression

  Through study completion, assessed up to three years.

• Deterioration of disease-related somatic symptoms

  Through study completion, assessed up to three years.

Other Outcomes (1)

• Pathological and molecular response

  At baseline and at the end of the 6th cycle of induction chemohormonal therapy (each cycle is 21 days).

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group start with 6 cycles of induction chemohormonal therapy followed with cytoreductive prostatectomy and postoperative adjuvant radiotherapy if needed. All patients continued maintenance therapy.

Drug: Systemic Chemohormonal Therapy; Drug: Systemic Hormonal Therapy; Procedure: Cytoreductive Prostatectomy; Procedure: Postoperative Adjuvant Radiotherapy

Control group

ACTIVE COMPARATOR

The control group start with 6 cycles of chemohormonal therapy followed by continued maintenance therapy.

Drug: Systemic Chemohormonal Therapy; Drug: Systemic Hormonal Therapy

Interventions

Systemic Chemohormonal Therapy DRUG

Under continuous ADT, docetaxel 75mg/m\^2 body surface area every 21 days, oral dexamethasone 7.5mg pretreatment 12h, 3h, 1h before each infusion of docetaxel, and a total of 10mg of prednisolone per day when needed according to the decision of the researcher (in the case of grade 3 and above neutropenia or peripheral edema); oral darolutamide 600mg twice per day, 21 days for one cycle, six cycles in total.

Control group; Experimental group

Systemic Hormonal Therapy DRUG

Under continuous ADT, oral darolutamide 600mg twice per day

Control group; Experimental group

Cytoreductive Prostatectomy PROCEDURE

Cytoreductive prostatectomy was performed after six cycles of neoadjuvant systemic chemohormonal therapy.

Experimental group

Postoperative Adjuvant Radiotherapy PROCEDURE

Postoperative adjuvant radiotherapy of prostate bed is performed, if margin positive, with conventional segmentation and the dose of 64-72Gy.

Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the purpose of this trial and sign a written informed consent;
• Men aged 18-85 years;
• have histologically or cytologically confirmed adenocarcinoma of the prostate;
• Have multiple metastatic disease, defined as follows: according to RECIST v1.1, metastatic disease was defined as metastatic foci detected on bone scans or measurable lymph nodes or soft tissue or visceral lesions above the aortic bifurcation. Lymph nodes were defined as measurable if their short-axis diameter was ≥15 mm; soft tissue/visceral lesions were defined as measurable if their long-axis diameter was ≥10 mm. and total number of metastatic lesions ≥ 5. Patients with only regional lymph node metastases (N1, below the aortic bifurcation) were not eligible for the study.
• At the investigator's discretion, patients must meet the indications for ADT and docetaxel;
• Patients have not received any prior local or systemic therapy for prostate cancer primary or metastasis.
• Eastern Cooperative Oncology Group (ECOG) score of 0-1;
• Blood count at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 10\^9/L, and platelet count ≥ 100 x 10\^9/L (patient has not received any colony-stimulating factor within 4 weeks or a transfusion or blood product within 7 days prior to blood collection)
• Serum alanine aminotransferase and/or aspartate aminotransferase ≤ 1.5 x Upper limit of normal (ULN), total bilirubin ≤ ULN, creatinine ≤ 2.0 x ULN.

You may not qualify if:

• Prior therapy: ADT, second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, any chemotherapy or immunotherapy for prostate cancer, radiotherapy (external radiation radiotherapy, brachytherapy, or radiopharmaceuticals);
• Known hypersensitivity to any of the investigational drugs, or excipients in the preparations;
• Contraindication to CT/MRI examination;
• Any of the following conditions within 6 months prior to randomization: stroke, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or congestive heart failure (New York Heart Association cardiac function class III or IV);
• uncontrolled hypertension as evidenced by a resting systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg after treatment
• History of prior malignancy, except basal cell or cutaneous squamous cell carcinoma in complete remission;
• History of gastrointestinal disorders or surgery expected to significantly interfere with the absorption of study drug(s);
• Active acute and chronic viral hepatitis, known HIV infection;
• Prior (28 days prior to initiation of study drug or 5 half-lives of investigational therapy from a prior study, whichever is longer) or concurrent participation in another clinical study of study drug;
• Any other serious or unstable medical condition or condition that may interfere with their participation in the study or the evaluation of study results or may jeopardize the safety of the trial and other conditions;
• Inability to swallow oral medications;
• A close interest in the research center.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (20)

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  BACKGROUND

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• 中国医促会泌尿健康促进分会, 中国研究型医院学会泌尿外科学专业委员会. 前列腺癌放射治疗安全共识. 现代泌尿外科杂志. 2019;24(5):336-46.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yinjie Zhu, Dr.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Liang Dong, Dr.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Dong

CONTACT

+86-13601613536; drdongliang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Fellow

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 12, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)