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Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

ConditionOligometastatic Prostate Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-75
SponsorChanghai Hospital

About this trial

The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed adenocarcinoma of the prostate without small cell features

Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT

<4 bone oligometastases, lymph node metastasis below the renal artery level

Expected survival time >5 years

Disqualifiers

Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.

Patients who have previously undergone transurethral resection or enucleation of the prostate.

Patients who have undergone other abdominal surgery within the last 3 months

Patients who have visceral metastases

Trial design

Design model

Parallel

Treatments tested in this trial

  • ADT combined with abiraterone

    Drug

    The patients will receive long-term ADT combined with abiraterone.

  • neoadjuvant hormone and RT

    Radiation

    The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: A (hormone)Active comparator 1 intervention
Group B: B (neoadjuvant hormone and RT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3-year progression-free survival (PFS)

To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).

Time frame
Assessment progression-free survival (PFS) at 3 years

Secondary outcomes

1

quality of life (QoL)

quality of life (QoL)

Time frame
through study completion, an average of 3 years
2

time to castration-resistant prostate cancer (CRPC)

To assess the time to castration-resistant prostate cancer (CRPC)

Time frame
through study completion, an average of 3 years
3

5-year overall survival (OS)

To assess the overall survival (OS)

Time frame
Assessment overall survival (OS) at 5 years

Other outcomes

Sponsors and contacts

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

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: