Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer

NCT06854250 | Recruiting Phase 2

• 2 other identifiers: 2024-FXY-295SL-B2024-623-02
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore whether androgen deprivation therapy combined with novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide is superior to the current treatment regimen of androgen deprivation therapy plus novel androgen receptor inhibitors for patients with metastatic prostate cancer. It will also learn about the safety of prostate cryoablation, and metronomic cyclophosphamide for patients with metastatic prostate cancer. The main questions it aims to answer are: Does prostate cryoablation, and metronomic cyclophosphamide delay the progression of metastatic prostate cancer? Does prostate cryoablation, and metronomic cyclophosphamide reduce symptomatic local events of metastatic prostate cancer? Researchers will explore if androgen deprivation therapy combined with novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide works to treat metastatic prostate cancer. Participants will: Receive treatment of androgen deprivation therapy and novel androgen receptor inhibitors until progression. Receive prostate cryoablation surgery and take cyclophosphamide. Visit the clinic every 1-3 months for checkups and tests. Keep a diary of their symptoms.

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic prostate cancer; Novel androgen receptor inhibitors; Prostate cryoablation; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• PSA progression-free survival

  Defined as the time from the initiation of androgen deprivation therapy to the occurrence of PSA progression or death.

  From date of initiation of androgen deprivation therapy until the date of PSA progression or date of death from any cause, whichever came first, assessed up to 5 years

Secondary Outcomes (4)

• Radiographic progression-free survival

  From date of initiation of androgen deprivation therapy until the date of radiographic progression or date of death from any cause, whichever came first, assessed up to 5 years

• mCRPC-free survival

  From date of initiation of androgen deprivation therapy until the date of progression to metastatic castration-resistant prostate cancer or date of death from any cause, whichever came first, assessed up to 5 years

• Overall survival

  From date of initiation of androgen deprivation therapy until the date of death from any cause, assessed up to 5 years

• Incidence of symptomatic local events

  Through study completion, an average of 3 year

Study Arms (1)

Prostate cryoablation and cyclophosphamide

EXPERIMENTAL

Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.

Procedure: Prostate cryoablation; Drug: Cyclophosphamide (CTX)

Interventions

Prostate cryoablation PROCEDURE

Enrolled patients will receive prostate cryoablation within 6 months of starting androgen deprivation therapy.

Prostate cryoablation and cyclophosphamide

Cyclophosphamide (CTX) DRUG

Enrolled patients will receive cyclophosphamide (50mg daily) one day after prostate cryoablation and continue for a total of six months.

Prostate cryoablation and cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males between 18 and 80 years old;
• Histopathological confirmation of prostatic acinar adenocarcinoma;
• Diagnosed with metastatic prostate cancer at initial diagnosis according to the AJCC 8th edition staging criteria;
• No progression at the time of initiating of prostate cryoablation;
• ECOG score of 0-1;
• Can tolerate general anesthesia and prostate cryoablation surgery;
• No significant abnormalities .
• Able to understand this study and sign the informed consent form.

You may not qualify if:

• Serious illness not suitable to receive the treatment regimen;
• Other malignant tumors (within 5 years), except for non-melanoma skin cancer;
• Receipt of treatments other than treatment regimen of this study;
• Prostate cancer invading the rectum;
• with prostate volumegreater than 55ml after 6 months of androgen deprivation therapy .

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

RECRUITING

Related Publications (6)

• Si T, Guo Z, Hao X. Combined cryoablation and GM-CSF treatment for metastatic hormone refractory prostate cancer. J Immunother. 2009 Jan;32(1):86-91. doi: 10.1097/CJI.0b013e31818df785.

  PMID: 19307997 BACKGROUND

• Donnelly BJ, Saliken JC, Brasher PM, Ernst SD, Rewcastle JC, Lau H, Robinson J, Trpkov K. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer. 2010 Jan 15;116(2):323-30. doi: 10.1002/cncr.24779.

  PMID: 19937954 BACKGROUND

• Shah TT, Peters M, Eldred-Evans D, Miah S, Yap T, Faure-Walker NA, Hosking-Jervis F, Thomas B, Dudderidge T, Hindley RG, McCracken S, Greene D, Nigam R, Valerio M, Minhas S, Winkler M, Arya M, Ahmed HU. Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. Eur Urol. 2019 Jul;76(1):98-105. doi: 10.1016/j.eururo.2018.12.030. Epub 2019 Jan 9.

  PMID: 30638633 BACKGROUND

• Tsuboi I, Matsukawa A, Kardoust Parizi M, Klemm J, Mancon S, Chiujdea S, Fazekas T, Miszczyk M, Laukhtina E, Kawada T, Katayama S, Iwata T, Bekku K, Karakiewicz P, Wada K, Roupret M, Araki M, Shariat SF. A Systematic Review and Meta-analysis of the Impact of Local Therapies on Local Event Suppression in Metastatic Hormone-sensitive Prostate Cancer. Eur Urol Oncol. 2024 Dec;7(6):1185-1194. doi: 10.1016/j.euo.2024.03.007. Epub 2024 Apr 4.

  PMID: 38575408 BACKGROUND

• Li Y, Wang N, Zhao D, Wang J, Jiang L, Wang Y, Chen D, Wu Z, Zhou F, Yang Z. Cytoreductive prostate cryoablation and metronomic cyclophosphamide for metastatic hormone-sensitive prostate cancer. Future Oncol. 2022 Jun;18(19):2373-2380. doi: 10.2217/fon-2021-1424. Epub 2022 Apr 20.

  PMID: 35440168 BACKGROUND

• Wang N, Ye Y, Deng M, Zhao D, Jiang L, Chen D, Wu Z, Wang Y, Li Z, Yang Z, Li J, Zhou F, Li Y. Prostate cryoablation combined with androgen deprivation therapy for newly diagnosed metastatic prostate cancer: a propensity score-based study. Prostate Cancer Prostatic Dis. 2021 Sep;24(3):837-844. doi: 10.1038/s41391-021-00335-2. Epub 2021 Mar 4.

  PMID: 33664457 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Zhenyu Yang, Dr.

CONTACT

86-1390229060; yangzy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 3, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)