Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

What Was Tested

The trial (phase 1) is built around Leuprolide and Goserelin.

It had 1 arm (groups): Treatment (hormone therapy, temsirolimus) (experimental).

The registry classes the interventions as drug and other.

More on the Plan

To archive tissue and blood components for future study of molecular markers of response and disease progression.

Treatment with temsirolimus continues for up to 36 weeks in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients may receive no more than 3 months of hormonal therapy, including therapy initiated within 2 months of study entry.

After completion of study therapy, patients are followed at 30 days.

Who Took Part

The registry lists 24 actual participants took part.

It was open to men only.

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

Examples of who could join: Patients must have histologically confirmed adenocarcinoma of the prostate recurring after local therapy (radical prostatectomy and/or radiation therapy) as evidenced by rising serum PSA. No evidence of metastasis as determined by bone scan or computed tomography (CT) scan. Initiation of Androgen Ablation of less than 8 weeks' duration prior to study entry is permitted. Leukocytes ≥ 3,000/mcl. Absolute neutrophil count ≥ 1,000/mcl.

The full record lists 19 inclusion and 9 exclusion criteria; among the exclusions: patients with histologic variants other than adenocarcinoma in the primary tumor; patients may not be receiving any other investigational agents; patients may not be receiving concomitant immunotherapy or immunosuppressive therapy.

How the Study Was Run

Design: 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 2007-09 with completion listed for 2008-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Leuprolide and Goserelin in 24 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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.