Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin for prostate inflammation.

This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer.

The names of the study drugs involved in this study are: * Androgen deprivation therapy (ADT) with a drug of your physician's choice.

This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon). * Docetaxel * Nivolumab.

It had three arms (groups): COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed Tumor (experimental), COHORT 2: Inflamed Tumor without DNA repair defects (DDRD) (experimental) and COHORT 3: Biomarker Negative (experimental).

The registry classes the interventions as drug.

More on the Plan

This research study is a Phase 2 clinical trial.

Food and Drug Administration (FDA) has not approved nivolumab for hormone sensitive prostate cancer.

However, nivolumab has been approved for other uses, including for advanced melanoma, lung cancer, head and neck cancer, kidney cancer, and bladder cancer.

FDA has not approved docetaxel as a treatment option for hormone sensitive prostate cancer.

Who Took Part

The registry lists 47 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: Newly diagnosed histologically confirmed prostate adenocarcinoma within 6 months prior to study registration with evidence of high-volume distant metastasis on conventional imaging. Distant metastasis is defined by non-regional lymph node(s) metastasis (M1a), bone metastasis (M1b), and/or other site(s) of metastatic disease (M1c). Conventional imaging consists of CT, MRI or radionuclide bone scan. High volume of disease is defined by presence of four or more bone lesions with at least one beyond the vertebral bodies or pelvis or any site of visceral metastasis. Age ≥18 years.

The full record lists 45 inclusion and 33 exclusion criteria; among the exclusions: subjects must not have received prior adt (lhrh analogue +/- antiandrogen), chemotherapy, or immunotherapy for prostate cancer. the following exception is allowed:; the 120-day window commences at the start of either the antiandrogen agent or lhrh analogue, whichever is earlier; second-generation hormonal agents (e.g., abiraterone acetate) are not allowed.

How the Study Was Run

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

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

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.

It started in 2020-05-11 with completion listed for 2025-07-29.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy (time frame: 7 months from the start of chemoimmunotherapy).

It also tracked 7 secondary outcomes, for example Percentage of Subjects With PSA Less Than or Equal to 0.2 ng/mL During the Chemoimmunotherapy Combination, Best Objective Response Rate in Subjects With Measurable Disease Per RECIST 1,1 Criteria, Overall Survival Rate at 3-years, Castration Resistant Disease-free Rate at 12 Months, Clinical Progression Free Rate at 7 Months and Serologic Progression Free Rate at 12 Months.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Leuprolide and Goserelin in 47 people with prostate inflammation.

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page and the Goserelin compound page, Prostate inflammation research.