Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

What Was Tested

This registered phase 2 trial tested Goserelin.

It had two arms (groups): Darolutamide Plus ADT (experimental) and ADT alone (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to men only aged from 18 years up to 75 years.

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

Examples of who could join: Patients must be ≥ 18 and ≤75 years of age. All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy. Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1. All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment. Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases; prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy; severe or uncontrolled concurrent infections.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

The Goserelin group and the comparison group ran side by side rather than switching.

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

It started in 2024-05-01 with completion listed for 2026-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pathologic Complete Response Rate (time frame: After 12 weeks of neoadjuvant therapy + RP + PLND). Proportion of Subjects With Minimal Residual Disease (time frame: After 12 weeks of neoadjuvant therapy + RP + PLND).

It also tracked 8 secondary outcomes, for example Rate of Stage Degradation, Rate of Positive Surgical Margins, Rate of Complete Serum Remission, Proportion of subjects without PSA progression, Imaging Response Rate and Recovery time of urinary continence (day).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 80 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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