← Back to Search

Hormone Therapy

Nivolumab + Radiation + Hormone Therapy for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Kosj Yamoah, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status: 0-1
Diagnosed with Grade Group 5 prostate cancer (PCa): Gleason grade 9 (4+5 or 5+4) or 10 (5+5) with >30% of cores involved; Any PSA or T-stage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug combination to see if it is safe, works well, and delays prostate cancer progression.

Who is the study for?
Men over 18 with advanced prostate cancer (Grade Group 5, Gleason grade 9 or 10) who are receiving their first treatment and have a good performance status. They must be able to follow the study procedures for its duration, have normal organ function, agree to use contraception if necessary, and not donate sperm during the study.Check my eligibility
What is being tested?
The trial is testing how safe and effective nivolumab (Opdivo™) is when combined with high-dose radiation therapy and hormone therapy in delaying prostate cancer progression. Participants will receive this combination as part of their initial treatment.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormonal gland problems like thyroid issues, fatigue, infusion reactions similar to allergic responses, lung issues like coughing or shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.
Select...
My prostate cancer is aggressive (Grade Group 5) with a high Gleason score.
Select...
I have a confirmed diagnosis of prostate cancer and am starting my first treatment.
Select...
I am a man aged 18 or older.
Select...
I am eligible for specific radiation therapy and hormone treatment.
Select...
My organs are functioning normally while I'm on nivolumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Safety Run In - Rate of Dose Limiting Toxicity (CTCAE V5.0)
Phase II: Relapse Free Survival Rate
Secondary outcome measures
Time to PSA Nadir

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Syncope
1%
Superior vena cava syndrome
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Cancer pain
1%
Neoplasm progression
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment4 Interventions
Post androgen deprivation therapy (ADT), participants will receive nivolumab, HDR brachytherapy and external beam radiation therapy, followed by a 2 year follow-up period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brachytherapy
2007
Completed Phase 3
~2100
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Nivolumab
2014
Completed Phase 3
~4750
Androgen Deprivation Therapy
2008
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,968 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,140 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,492 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,403 Patients Enrolled for Prostate Cancer
Kosj Yamoah, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
300 Total Patients Enrolled
2 Trials studying Prostate Cancer
300 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03543189 — Phase 1 & 2
Prostate Cancer Research Study Groups: Combination Therapy
Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy Highlights & Side Effects. Trial Name: NCT03543189 — Phase 1 & 2
Androgen Deprivation Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03543189 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants that can join this trial?

"Affirmative, based on the information available at clinicaltrials.gov this research study is actively enrolling participants. It was first posted in October 3rd 2018 and last revised November 11th 2022 - with 44 patients needed to be enrolled from 1 site."

Answered by AI

Could you please summarize the previous research conducted with Nivolumab?

"Currently, 718 clinical trials related to Nivolumab are being conducted with 82 of these studies in their final phase. The majority of the tests for this treatment take place in Zürich, but there are 40285 locations where trials can be found."

Answered by AI

What conditions commonly necessitate the administration of Nivolumab?

"Nivolumab is widely known to treat malignant neoplasms, but also has demonstrated efficacy in treating other severe conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Does this trial offer a pioneering approach to treatment?

"Since 2012, when Ono Pharmaceutical Co. Ltd first conducted their Phase 1 & 2 study of Nivolumab with 659 participants in it, a total of 718 live studies for this drug have been launched across 2356 cities and 49 countries globally. 276 research trials dedicated to investigating the efficacy of Nivolumab have been completed since its inception."

Answered by AI

Is recruitment of participants still occurring for this experiment?

"Affirmative. The online portal clinicaltrials.gov showcases that this medical experiment, which was first published on October 3rd 2018, is presently looking for recruits. Approximately 44 people must be enrolled from a single location."

Answered by AI
~5 spots leftby Dec 2024