## Protocol Section
### Identification Module
**NCT ID:** NCT06437496

**Brief Title:** 68Ga-AAZTA-093 PET/CT: First-in-human Study

**Official Title:** 68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer

#### Organization Study ID Info
**ID:** FirstAHFujian-68Ga-AAZTA-093
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** First Affiliated Hospital of Fujian Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.

**Detailed Description:** Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the AAZTA chelator for labeling with 68Ga(III). This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PET/CT in the same group of prostate cancer patients.

### Conditions Module

**Conditions:**

- Malignant Neoplasm of Prostate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Drug: 68Ga-AAZTA-093 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT.

**Intervention Names:**

- Drug: 68Ga-AAZTA-093

**Label:** 68Ga-AAZTA-093 PET/ CT

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Drug: 68Ga-PSMA-11/68Ga-PSMA-617 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11/68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.

**Intervention Names:**

- Drug: 68Ga-PSMA-11//68Ga-PSMA-617

**Label:** 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 68Ga-AAZTA-093 PET/ CT

**Description:** Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT.

**Name:** 68Ga-AAZTA-093

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT

**Description:** Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11//68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.

**Name:** 68Ga-PSMA-11//68Ga-PSMA-617

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Sensitivity and Specificity of 68Ga-AAZTA-093 for prostate cancer in comparison with 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.

**Measure:** Diagnostic value

**Time Frame:** through study completion, an average of 3 months

**Description:** Compare the SUV of tumors between 68Ga-AAZTA-093 PET/CT and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.

**Measure:** SUV of tumors

**Time Frame:** through study completion, an average of 3 months

#### Primary Outcomes

**Description:** The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

**Measure:** Safety evaluation

**Time Frame:** Within 7 days following PET/CT

#### Secondary Outcomes

**Description:** Calculate the absorbed dose of 68Ga-AAZTA-093 in normal organs.

**Measure:** Dosimetry data

**Time Frame:** through study completion, an average of 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* confirmed treated or untreated prostate cancer patients;
* 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** miaoweibing@126.com

**Name:** Weibing Miao, MD

**Phone:** 86-0591-87981618

**Role:** CONTACT

**Contact 2:**

**Email:** guochang1007@163.com

**Name:** Guochang Wang, MD

**Phone:** 86-0591-87981619

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Email:** guochang1007@163.com

- **Name:** Guochang Wang, MD

- **Phone:** 86-0591-87981619

- **Role:** CONTACT

**Country:** China

**Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

**State:** Fujian

**Status:** RECRUITING

**Zip:** 350005

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- 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: Malignant Neoplasm of Prostate

- 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: D000009369

- Term: Neoplasms

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000019275

- Term: Radiopharmaceuticals

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M352637

- Name: Gallium 68 PSMA-11

- Relevance: HIGH

- As Found: Noise

- ID: M21258

- Name: Radiopharmaceuticals

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000718244

- Term: Gallium 68 PSMA-11

### Misc Info Module

- Version Holder: 2024-05-31
