CLINICAL TRIAL

Nivolumab for Prostate Cancer

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Recruiting · 18+ · Male · Boston, MA

Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer

See full description

About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms · Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Nivolumab
DRUG
Experimental Group 2
Nivolumab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Side Effect Profile for DOCETAXEL

DOCETAXEL
Show all side effects
40%
Fatigue
32%
Neutropenia
29%
Anaemia
29%
Dyspnoea
27%
Decreased appetite
26%
Diarrhoea
25%
Nausea
22%
Alopecia
21%
Asthenia
19%
Cough
19%
Pyrexia
15%
Constipation
13%
Vomiting
12%
Neuropathy peripheral
12%
Myalgia
12%
Arthralgia
12%
Oedema peripheral
10%
Febrile neutropenia
10%
Mucosal inflammation
9%
Back pain
9%
Chest pain
9%
Dizziness
9%
Rash
8%
Hyperglycaemia
8%
Pneumonia
7%
Abdominal pain
7%
Malignant neoplasm progression
7%
Leukopenia
7%
Headache
7%
Haemoptysis
6%
White blood cell count decreased
6%
Neutrophil count decreased
6%
Paraesthesia
5%
Bone pain
5%
Musculoskeletal pain
5%
Insomnia
5%
Weight decreased
3%
Hypomagnesaemia
3%
Upper respiratory tract infection
3%
Bronchitis
2%
Musculoskeletal chest pain
2%
Infection
2%
Respiratory failure
2%
Atrial fibrillation
2%
Pruritus
2%
Sepsis
2%
Dehydration
2%
Cerebrovascular accident
2%
Pulmonary haemorrhage
2%
Lung infection
2%
Pulmonary embolism
1%
Neutropenic infection
1%
Pleural effusion
1%
Skin infection
1%
Hypoglycaemia
1%
Clostridium difficile colitis
1%
Tumour pain
1%
Metastases to central nervous system
1%
Cardiac tamponade
1%
Enterocolitis infectious
1%
Intestinal perforation
1%
Mental status changes
1%
Aphasia
1%
Confusional state
1%
Goitre
1%
Superior vena cava syndrome
1%
Septic shock
1%
Bronchopneumonia
1%
Chills
1%
Dysphonia
1%
Pneumothorax
1%
Oropharyngeal pain
1%
Hyponatraemia
1%
Delirium
1%
Arterial haemorrhage
1%
Chronic obstructive pulmonary disease
1%
Cardio-respiratory arrest
1%
Acute respiratory failure
1%
Stridor
1%
Febrile bone marrow aplasia
1%
Calculus ureteric
1%
Interstitial lung disease
1%
VIIth nerve paralysis
1%
Peripheral sensory neuropathy
1%
Pancytopenia
1%
Urinary tract infection
1%
Respiratory tract infection
0%
Dysphagia
0%
Ischaemic stroke
0%
Hypothyroidism
0%
Lower respiratory tract infection
0%
Atrial thrombosis
0%
General physical health deterioration
0%
Spinal cord compression
0%
Sudden death
0%
Hypophosphataemia
0%
Generalised tonic-clonic seizure
0%
Sinus bradycardia
0%
Hypercalcaemia
0%
Pneumonitis
0%
Myasthenic syndrome
0%
Peripheral ischaemia
0%
Pulmonary thrombosis
0%
Convulsion
0%
C-reactive protein increased
0%
Tubulointerstitial nephritis
0%
Lobar pneumonia
Fatigue
40%
Neutropenia
32%
Anaemia
29%
Dyspnoea
29%
Decreased appetite
27%
Diarrhoea
26%
Nausea
25%
Alopecia
22%
Asthenia
21%
Cough
19%
Pyrexia
19%
Constipation
15%
Vomiting
13%
Neuropathy peripheral
12%
Myalgia
12%
Arthralgia
12%
Oedema peripheral
12%
Febrile neutropenia
10%
Mucosal inflammation
10%
Back pain
9%
Chest pain
9%
Dizziness
9%
Rash
9%
Hyperglycaemia
8%
Pneumonia
8%
Abdominal pain
7%
Malignant neoplasm progression
7%
Leukopenia
7%
Headache
7%
Haemoptysis
7%
White blood cell count decreased
6%
Neutrophil count decreased
6%
Paraesthesia
6%
Bone pain
5%
Musculoskeletal pain
5%
Insomnia
5%
Weight decreased
5%
Hypomagnesaemia
3%
Upper respiratory tract infection
3%
Bronchitis
3%
Musculoskeletal chest pain
2%
Infection
2%
Respiratory failure
2%
Atrial fibrillation
2%
Pruritus
2%
Sepsis
2%
Dehydration
2%
Cerebrovascular accident
2%
Pulmonary haemorrhage
2%
Lung infection
2%
Pulmonary embolism
2%
Neutropenic infection
1%
Pleural effusion
1%
Skin infection
1%
Hypoglycaemia
1%
Clostridium difficile colitis
1%
Tumour pain
1%
Metastases to central nervous system
1%
Cardiac tamponade
1%
Enterocolitis infectious
1%
Intestinal perforation
1%
Mental status changes
1%
Aphasia
1%
Confusional state
1%
Goitre
1%
Superior vena cava syndrome
1%
Septic shock
1%
Bronchopneumonia
1%
Chills
1%
Dysphonia
1%
Pneumothorax
1%
Oropharyngeal pain
1%
Hyponatraemia
1%
Delirium
1%
Arterial haemorrhage
1%
Chronic obstructive pulmonary disease
1%
Cardio-respiratory arrest
1%
Acute respiratory failure
1%
Stridor
1%
Febrile bone marrow aplasia
1%
Calculus ureteric
1%
Interstitial lung disease
1%
VIIth nerve paralysis
1%
Peripheral sensory neuropathy
1%
Pancytopenia
1%
Urinary tract infection
1%
Respiratory tract infection
1%
Dysphagia
0%
Ischaemic stroke
0%
Hypothyroidism
0%
Lower respiratory tract infection
0%
Atrial thrombosis
0%
General physical health deterioration
0%
Spinal cord compression
0%
Sudden death
0%
Hypophosphataemia
0%
Generalised tonic-clonic seizure
0%
Sinus bradycardia
0%
Hypercalcaemia
0%
Pneumonitis
0%
Myasthenic syndrome
0%
Peripheral ischaemia
0%
Pulmonary thrombosis
0%
Convulsion
0%
C-reactive protein increased
0%
Tubulointerstitial nephritis
0%
Lobar pneumonia
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01642004) in the DOCETAXEL ARM group. Side effects include: Fatigue with 40%, Neutropenia with 32%, Anaemia with 29%, Dyspnoea with 29%, Decreased appetite with 27%.

Eligibility

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
, and testosterone level of less than 50 ng/dL A man who has had a radical prostatectomy (RP) and has any detectable rising PSA after RP (or after salvage RT if performed), a minimum PSA of 1.0 at the time of screening, and a testosterone level of less than 50 ng/dL should be considered for TRT. show original
Patients must have a history of prostate adenocarcinoma (adenocarcinoma must be the primary histology; secondary components of variant histologies are acceptable), confirmed on biopsy, and treated with RP or definitive radiation (RT). show original
If a diagnostic core biopsy is only available, at least 3 cores must be involved by tumor show original
A PSA doubling time of less than 10 months is associated with a high likelihood of prostate cancer. show original
Patients must have agreed to participate in the study and been given information about it before the study begins. show original
value and ≥0.2 ng/mL above the pre-treatment value show original
No evidence of cancer spread was found on conventional imaging (CT or MRI scans plus a bone scan). show original
The interval between the first and last PSA values is greater than or equal to 8 weeks, but less than or equal to 12 months. show original
If you are a patient who has received primary radiation therapy, a prostatectomy specimen or a diagnostic core biopsy is mandatory show original
At least 3 consecutive PSA values that each measure ≥0. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 1 primary outcome and 6 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 12 weeks.

Disease Control
12 WEEKS
Proportion of patients with high-risk biochemically-recurrent (BCR) prostate cancer (PCa) that experiences decline or stabilization in PSA (without symptomatic/radiographic progression) after 12 weeks of nivolumab treatment
12 WEEKS
Best PSA response during nivolumab treatment as an absolute change relative to baseline
2 YEARS
2 YEARS
Treatment-related adverse events as assessed by CTCAE v5.0
2 YEARS
2 YEARS
Time from enrollment to development of radiographic metastatic disease
2 YEARS
2 YEARS
Time from enrollment to initiation of androgen deprivation therapy (ADT)
2 YEARS
2 YEARS
Change in PSA doubling time (PSADT) at end-of-study relative to baseline
2 YEARS
2 YEARS
See More

Who is running the study

Principal Investigator
D. J. E.
David J. Einstein, MD
Beth Israel Deaconess Medical Center

Patient Q & A Section

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

Can prostate cancer be cured?

Prostatic tumourigenesis may be associated at least to some degree with alterations in the PTEN protein. The PTEN protein may thus represent a new target for the treatment of prostate cancer.

Anonymous Patient Answer

What is prostate cancer?

Prostate cancer is a tumor that forms in the prostate and can spread throughout the body, often in the form of a hormone-sensitive, localized prostate cancer. The disease is most common in men older than 65 years. Cancer can spread throughout the body or to the bones in the lower part of the body. The average age of men affected by prostate cancer is 69 years. Patients usually do not survive more than two years from the time prostate cancer is diagnosed. However, with treatment, the chance of surviving five years is 50% or more.

Anonymous Patient Answer

What are common treatments for prostate cancer?

Prostate cancer is a very common malpractice, with men being treated in any given area of the country. However, there is a high prevalence of low grade tumors and these appear to be more likely to be treated surgically. The treatment strategies and rates employed vary across the developed and developing world. The most prevalent treatment for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in developed countries is radiotherapy, which is delivered through external beam techniques. In the developing world, radical prostatectomy and hormonal therapy remain the predominant treatments employed. New techniques with better indications and outcomes are emerging in the developed world. The number of centres providing prostate cancer treatment is increasing. More prospective trials are warranted to further define the optimal treatment strategy for prostate cancer.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

The incidence of PCa is increasing drastically worldwide. Men in the US do not only have a higher prevalence rate of PCa compared to their Western counterparts but also a higher incidence rate. However, as a result of lower detection rates of early-stage PCa in America, a lower mortality rate has been observed in US men.

Anonymous Patient Answer

What are the signs of prostate cancer?

Symptoms of PCa are as follows: urinary urgency, hesitancy and incontinence, difficulty in starting an erection, hematuria, dysuria and pelvic pain. More than 50 % of patients have  symptoms that affect their sleep and their relationship with their partner. Patients usually prefer to go to healthcare facilities for treatments rather than be treated at home. Therefore, when diagnosing a patient with symptoms, a medical professional has to evaluate all the symptoms of patients according to the following factors: age of the patient,  clinical characteristics of the patient, other family members' symptoms,  information of patients and their  partner about this patient's  symptoms.

Anonymous Patient Answer

What causes prostate cancer?

At a more detailed level, [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is a syndrome. It is a result of multiple genetic and environmental factors that interfere with the normal development of the prostate, making its cells and cells of the sex nerves more prone to problems.

Anonymous Patient Answer

How does nivolumab work?

Nivolumab showed a therapeutic benefit in a dose dependent fashion in a range of immunotherapy-naive and –experienced patients with metastatic HR-positive, HER2-positive early-phase [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer).<br><br>

  1. The study was performed with permission by the Department for the Fight against Cancer and its related organizations<br>\n2.
Anonymous Patient Answer

Have there been other clinical trials involving nivolumab?

While studies are ongoing with different drugs and treatment regimens, there is an expectation that nivolumab will be a safe and effective treatment in a range of indications.

Anonymous Patient Answer

What are the common side effects of nivolumab?

Patients receiving nivolumab reported higher incidence of fatigue, diarrhea, nausea/vomiting, constipation, and rash compared to patients receiving placebo. The most frequent side effect requiring treatment interruption was fatigue. Nivolumab, when used in men inadequately responding to chemotherapy, can be a potential treatment option to treat elderly men with castration-resistant and metastatic prostate cancer with significant symptomatology.

Anonymous Patient Answer

Is nivolumab typically used in combination with any other treatments?

In patients with metastatic renal cell or papillary renal cell cancer receiving nivolumab, combination treatments comprised of nivolumab were associated with a relatively lower incidence of disease progression or death from cancer compared with other treatments and the prognoses were similar to those reported in the NICE guidance for advanced renal cell cancer (NCT 01542570). Results from a recent clinical trial do not indicate an superiority for combinations. Moreover, the use of nivolumab in combination treatment with other treatments for advanced renal cell cancer does not have to be replaced by a PSA-guided approach.

Anonymous Patient Answer

What are the chances of developing prostate cancer?

Results from a recent clinical trial indicated significant likelihood of developing prostate adenocarcinoma. Results from a recent clinical trial may be used to help men avoid unnecessary screening.

Anonymous Patient Answer

Does nivolumab improve quality of life for those with prostate cancer?

We found that a single intravenous infusion of nivolumab caused significant improvements in health-related quality of life among men with prostate cancer who had recently received androgen deprivation therapy and who had had persistent disease progression on androgen deprivation therapy. In a recent study, findings from this randomized, double-blind, placebo-controlled trial suggest that a single intravenous infusion of nivolumab may improve quality of life in men with metastatic prostate cancer.

Anonymous Patient Answer
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