Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

What Was Tested

The trial (phase 2) is built around Triptorelin.

It had two arms (groups): Androgen Deprivation Therapy with Docetaxel (experimental) and ADT alone (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 75 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. All patients must undergo thorough tumor staging and meet one of the following criteria:. Multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,. Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible; patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible; patients with severe or uncontrolled concurrent infections are not eligible.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Being open-label, the Triptorelin study did not mask who received what.

It started in 2018-12-12 with completion listed for 2020-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic Complete Response Rate (time frame: up to 8 months). pCR or MRD rate (time frame: up to 8 months).

It also tracked 15 secondary outcomes, for example Imaging Response Rate, Rate of Stage Degradation, Rate of Positive Surgical Margins, Rate of Complete Serum Remission, Operative time (min) and Estimated blood loss (ml).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 75 people.

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

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