Clinical trial · Interventional
Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer
Androgen Deprivation Therapy Combined With Novel Androgen Receptor Inhibitors, Prostate Cryoablation, and Cyclophosphamide in the Treatment of Newly Diagnosed, Metastatic Prostate Cancer: A Single-Center, Single-Arm, Prospective Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (CTX) | Drug | Cyclophosphamide | ALIAS |
| Prostate cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate cryoablation and cyclophosphamide
- description
- Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.
- interventionNames
- Procedure: Prostate cryoablation
- Drug: Cyclophosphamide (CTX)
Primary outcomes (1)
- measure
- PSA progression-free survival
- timeFrame
- 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
- description
- Defined as the time from the initiation of androgen deprivation therapy to the occurrence of PSA progression or death.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 .
References
Publications (6)
- BACKGROUNDSi 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
- BACKGROUNDDonnelly 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
- BACKGROUNDShah 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
- BACKGROUNDTsuboi 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
- BACKGROUNDLi 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
- BACKGROUNDWang 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.