ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study (PCS XIV)

What Was Tested

The trial (phase 3) is built around Goserelin.

High-risk prostate cancer is usually treated with a combination of radiation therapy and hormone therapy (ADT).

Radiation destroys cancer cells, while ADT lowers testosterone, a hormone that prostate cancer cells need to grow.

Together, these treatments help control the cancer.

It had two arms (groups): Arm 1 (experimental): 12 months of ADT + Radiotherapy (experimental) and Arm 2 (standard of care): 24 months of ADT + Radiotherapy (active comparator).

Zoladex is given for 12 months instead of 24.

The registry classes the interventions as drug.

Who Took Part

The registry lists 600 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: • Able to understand and sign informed consent form (ICF);. Males aged ≥ 18 years;. Histologically confirmed adenocarcinoma of the prostate;. Participants with high-risk prostate cancer according to either of the following:. PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC);.

The full record lists 13 inclusion and 17 exclusion criteria; among the exclusions: • prior local or systemic therapy for prostate cancer (e.g. adt, chemotherapy or novel androgen receptor inhibitors \[aris\]);; PSMA-PET positive nodal or distant metastases;; evidence of nodal or distant metastases on conventional imaging;.

How the Study Was Run

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

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2026-10 with completion listed for 2035-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 5-year biochemical failure-free survival (bFFS) (time frame: 5 years).

It also tracked 10 secondary outcomes, for example Metastasis-free survival, Overall survival, Prostate cancer-specific mortality, 8-year biochemical failure-free survival (bFFS), Toxicity - Acute and Toxicity - Late.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 600 people.

With 600 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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