Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide and Goserelin for low testosterone (without or alongside trt).

It had three arms (groups): Arm I (SST) (active comparator), Arm II (SST, prostatectomy or radiation therapy) (experimental) and Step 1 (pre-randomization) (active comparator).

Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.

Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.

Standard treatment data collection prior to randomization.

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

More on the Plan

To compare the rate of symptomatic local progression between the treatment arms.

To compare progression-free survival (PFS) between the two treatment arms.

To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.

QUALITY OF LIFE OBJECTIVES: I.

Who Took Part

The registry lists 1273 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: STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST. STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration. STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies. STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies. STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.

The full record lists 24 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Leuprolide study: the low testosterone (without or alongside trt) participants and staff both knew the treatment.

It started in 2018-09-24 with completion listed for 2033-04-01.

It ran at 338 sites in United States (334), Chile (1), Colombia (1), Mexico (1) and Switzerland (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Overall survival (OS).

It also tracked 3 secondary outcomes, for example Media OS, Rate of symptomatic local progression and Progression-free survival (PFS).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Goserelin in 1273 people with low testosterone (without or alongside trt).

With 1273 participants it is a large trial for this field.

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

More context: the Leuprolide compound page and the Goserelin compound page, Low testosterone (without or alongside TRT) research.