Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

What Was Tested

This registered phase 2 trial tested Degarelix.

This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy.

Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed.

If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy.

It had 1 arm (groups): ADT + chemotherapy (other).

Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.

The registry classes the interventions as drug.

More on the Plan

This is an open-label, single-arm study of neoadjuvant ADT and chemotherapy in subjects with non-metastatic, locally-advanced prostate cancer who are eligible for radical prostatectomy.

Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy.

Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest.

In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.

Who Took Part

Enrollment: 4 actual participants took part.

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: Recent (\<6 weeks prior to study entry) negative bone scan and CT of the chest and abdomen. Appropriate surgical candidate for radical prostatectomy and a performance status of \<2 (ECOG scale). Adequate bone marrow function as defined as an absolute peripheral granulocyte count \>1500 and platelet count \>100,000. Adequate hepatic function per the following criteria:. AST and ALT ≤5 x ULN.

The full record lists 12 inclusion and 13 exclusion criteria; among the exclusions: prostatic adenocarcinoma with neuroendocrine differentiation or small cell features; surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first adt and chemotherapy treatment; previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or investigational study drug.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-10 with completion listed for 2017-09-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Safety of Drug Regimen as Measured by Number of Adverse Events and Surgical Morbidity as Measured by Number of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Degarelix in 4 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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