## Protocol Section
### Identification Module
**NCT ID:** NCT06435702

**Brief Title:** Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

**Official Title:** A Prospective Observational Cohort Study of Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy

#### Organization Study ID Info
**ID:** LM2023526
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2029-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Bayer

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University Third Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.

**Detailed Description:** This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer. The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer, using time to achieve CRPC as the primary study endpoint. OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint. It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer. It is divided into a screening period, a treatment period and a follow-up period. Patients will enter the screening period from the time they sign the informed consent form, and those who have been evaluated and qualified in the screening period will be entered into the study. Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment + darotarotide adjuvant therapy with or without combination radiotherapy at the investigator's discretion.

### Conditions Module

**Conditions:**

- Prostate Cancer

**Keywords:**

- Lymph Node-positive

- Prostate Cancer

- Radical Prostatectomy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 108

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.

**Intervention Names:**

- Drug: Darolutamide in addition to androgen deprivation therapy

**Label:** Darolutamide in addition to androgen deprivation therapy

#### Arm Group 2

**Description:** The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.

**Intervention Names:**

- Drug: androgen deprivation therapy only

**Label:** androgen deprivation therapy only

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Darolutamide in addition to androgen deprivation therapy

**Description:** Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration

**Name:** Darolutamide in addition to androgen deprivation therapy

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- androgen deprivation therapy only

**Description:** The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.

**Name:** androgen deprivation therapy only

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** castrate resistant prostate cancer

**Measure:** Time to CRPC

**Time Frame:** Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first.

#### Secondary Outcomes

**Description:** metastasis-free survival

**Measure:** MFS

**Time Frame:** Time to metastasis or death confirmed from enrollment imaging, whichever occurred first

**Description:** radiography Progression-Free-Survival

**Measure:** rPFS

**Time Frame:** Time from initiation to imaging progression or death from any cause, whichever occurs first

**Description:** radiography Progression-Free-Survival

**Measure:** PSA-PFS

**Time Frame:** Time from initiation to PSA progression or death, whichever occurs first

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. patients voluntarily enrolled in the study and signed an informed consent form; 2. aged 18-80 years (including 18 and 80 years), male; 3. diagnosed with prostate adenocarcinoma by pathology or cytology; 4. Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score 0-1. 5. patients who have undergone radical prostatectomy (RP) and pelvic lymph node dissection (PLND) without non-regional lymph node metastasis, bone metastasis, or metastasis to other sites (e.g., visceral metastasis) as confirmed by conventional imaging (bone imaging, CT, or MRI) or PSMA PET/CT 6. have positive postoperative pathologic lymph nodes (pN1); 7. with their consent and have signed an informed consent form.

Exclusion Criteria:

* Patients will not be enrolled if they have any of the following:

  1. have histologic features of neuroendocrine differentiation or small cell carcinoma;
  2. have received prior treatment for prostate cancer: postoperative systemic therapy including ADT for \>3 months, conventional endocrine therapy (e.g., flutamide, bicalutamide) for \>3 months, novel endocrine therapy (e.g., dalotamide, abiraterone, abatacept, enzalutamide), chemotherapy (e.g., docetaxel), immunotherapy, and targeted therapies
  3. Inability to tolerate Darotamine or ADT treatment;
  4. persons who are allergic or have a known history of allergy to darotarolimide or ADT;
  5. other conditions that the investigator considers inappropriate for inclusion.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study population consisted of patients with non-metastatic prostate cancer who underwent radical prostatectomy with positive pathologic lymph nodes

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bysy@bjmu.edu.cn

**Name:** Shudong Zhang, MD

**Phone:** +86 010-82266699

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** bysy@bjmu.edu.cn

- **Name:** Shudong Zhang, MD

- **Phone:** +86 010-82266699

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Third Hospital

**State:** Beijing

**Zip:** 100191

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000004967

- Term: Estrogens

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000045930

- Term: Anabolic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M4059

- Name: Androgens

- Relevance: HIGH

- As Found: Assistance

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M4513

- Name: Ascorbic Acid

- Relevance: HIGH

- As Found: Assistance

- ID: M11751

- Name: Methyltestosterone

- Relevance: HIGH

- As Found: Assistance

- ID: M16509

- Name: Testosterone

- Relevance: LOW

- As Found: Unknown

- ID: M223475

- Name: Testosterone undecanoate

- Relevance: LOW

- As Found: Unknown

- ID: M223485

- Name: Testosterone enanthate

- Relevance: LOW

- As Found: Unknown

- ID: M235012

- Name: Testosterone 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M8115

- Name: Estrogens, Conjugated (USP)

- Relevance: HIGH

- As Found: Assistance

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M3032

- Name: Anabolic Androgenic Steroids

- Relevance: LOW

- As Found: Unknown

- ID: M25605

- Name: Anabolic Agents

- Relevance: LOW

- As Found: Unknown

- ID: T477

- Name: Vitamin C

- Relevance: LOW

- As Found: Unknown

- ID: T437

- Name: Ascorbic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001205

- Term: Ascorbic Acid

- ID: D000008777

- Term: Methyltestosterone

- ID: D000000728

- Term: Androgens

- ID: D000004966

- Term: Estrogens, Conjugated (USP)

### Misc Info Module

- Version Holder: 2024-05-31
