An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer

• Sponsor: Zhujiang Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04997252
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.

Condition or Disease	Intervention/Treatment	Phase
High-Risk and Oligometastatic Prostate Cancer	Drug: Apalutamide	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
• Anticipated Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high-risk and oligometastatic prostate cance Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues	Drug: Apalutamide; apalutamide as neoadjuvant therapy

Outcome Measures

Primary Outcome Measures

1. rPFS [Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

   radiographic progression-free survival

Secondary Outcome Measures

1. pCR [preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

   pathological complete response

2. PFS [preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

   positive margin rate; progression-free survival

3. PSA response rate: [preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

   more than 50% decrease from baseline

4. TTPP [preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

   time to PSA progression

5. time to BCR after surgery [preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

6. pathological stage [preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult males aged above 18 years old, no healthy volunteers included;

2. Prostate cancer confirmed by pathological findings;

3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;

4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;

5. ECOG score of 0 - 1

6. Agreement to undergo preoperative and postoperative endocrine therapy;

7. Voluntary signing of an ICF for the clinical trial

Exclusion Criteria:

1. Any other tumor disease requiring treatment;

2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;

3. A history of epilepsy or any condition that may lead to seizures;

4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Binshen Chen, associate chief physician, Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT04997252
• Other Study ID Numbers: Chen-001
• First Posted: Aug 9, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Aug 9, 2021