Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

Oligo-metastatic prostate cancer (OMPCa) is considered as an intermediated state between localized and poly-metastatic disease.

The investigators here to conduct a unique clinical trial which OMPCa patients were confirmed by conventional imaging, and received a long-term enhanced systemic therapy accompanied by tumor-directed therapy.

It had 1 arm (groups): systemic treatment combined with radical treatment and radiotherapy (experimental).

The registry classes the interventions as drug, procedure and radiation.

More on the Plan

The investigators thus designed a distinct clinical trial including patients who were confirmed as oligo-metastatic disease by conventional imaging modality (CT, MRI and ECT) rather than PSMA PET-CT.

This study also aimed to evaluate the therapeutic effects of tumor-directed treatment under the background of long-term enhanced systemic therapy, including abiraterone, enzalutamide or apalutamide.

Who Took Part

The registry lists 160 planned participants were the target.

It was open to men only aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged between 18 and 80;. The metastatic lesions should meet the following the criteria:. Metastases are limited to bone or lymph nodes;. Visceral metastases are not allowed;. Radiographic observed pelvic lymph node metastasis with a diameter of \>2cm should also be considered as one metastatic lesion.

The full record lists 17 inclusion and 21 exclusion criteria; among the exclusions: received prior local treatment for primary lesion or metastatic lesions, including radical prostatectomy, radical radiotherapy, surgery or radiotherapy to metastatic lesion;; received prior systemic treatment for prostate cancer longer than 1 month;; received prior castration combined with new-generation androgen signaling pathway inhibitors such as abiraterone, apalutamide or enzalutamide; castration combined with docetaxel chemotherapy;.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-04 with completion listed for 2024-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Two years' radiographic progression-free survival (rPFS) (time frame: 2 years).

It also tracked 3 secondary outcomes, for example Two years' overall survival (OS), Two years' PSA progression-free survival (PSA-PFS) and Pathological complete response (pCR) or minimal residual disease (MRD) rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide and Goserelin in 160 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page and the Goserelin compound page, all human trials.