Health TrialsbyHealthPanel

Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer

ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Prostate cryoablation

    Procedure/Surgery

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

  • Cyclophosphamide (CTX)

    Drug

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

Treatment groups

104 Participants
are divided into 1 treatment group
Group A: Prostate cryoablation and cyclophosphamideExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
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

1

Radiographic progression-free survival

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

Time frame
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
2

mCRPC-free survival

Defined as the time from the initiation of androgen deprivation therapy to progression to metastatic castration-resistant prostate cancer (mCRPC) or death.

Time frame
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
3

Overall survival

Defined as the time from the initiation of androgen deprivation therapy to death from any cause.

Time frame
From date of initiation of androgen deprivation therapy until the date of death from any cause, assessed up to 5 years
4

Incidence of symptomatic local events

Symptomatic local events are defined as any of the following conditions: urinary tract infection, indwelling catheterization, acute kidney injury, transurethral resection of the prostate, urinary obstruction, indwelling ureteral stent placement, nephrostomy, colostomy, or surgery for intestinal obstruction.

Time frame
Through study completion, an average of 3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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