Prostate CancerPRO-TESTNCT02954783
PROstaTe Cancer - Exercise-STudy (PRO-TEST)
A study testing High Intensity Interval Training in people with Prostate Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background and purpose: The purpose of this study is to investigate the effect of exercise on intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer undergoing radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically verified localized prostate cancer
- Eligible for curative radical prostatectomy
Who cannot join
- Any other known malignancy requiring active treatment
- Performance status > 1
- Ongoing treatment with beta blockers
- Physical disabilities precluding physical testing and/or exercise
- Inability to read and understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, DK-2100
About this study
Official title: Effect of Different Exercise Regimens on Intratumoral Natural Killer (NK) Cell Variability in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study
Background and purpose: The purpose of this study is to investigate the effect of exercise on intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer undergoing radical prostatectomy.
The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural killer (NK)-cell infiltration in patients with localized prostate cancer, and that the infiltration is greater in patients performing High Intensity Interval Training compared to usual care controls.
Read more
Currently there is a lack of randomized controlled trials examining different types of exercise in patients with localized prostate cancer. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.
Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.
Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either High Intensity Interval Training (HIIT) exercise intervention or observational control receiving usual care from inclusion and until planned surgery (radical prostatectomy).
All patients will undergo assessments at inclusion (baseline) and at follow-up after the exercise intervention period (maximum 8 weeks) 3-5 days prior to surgery.
Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality of life by self-report questionnaires; fasting blood sample measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and inflammatory markers.
Biological tissue from tumor (primary prostate biopsies) will be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.
Read the detailed description
The purpose of this study is to investigate the effect of exercise on the variability of intratumoral Natural Killer (NK)-cell infiltration in tumor biopsies taken before and after an exercise intervention in patients randomized 2:1 to one of two study arms: I) High Intensity Interval Training (HIIT) (N=20) or II) usual care, prior to radical prostatectomy.
In addition to this the investigators wish to investigate the effect of HIIT exercise on the infiltration of other immune cells into the tumor, tumor vessel morphology, modulation of tumor-metabolism, -biology and signaling.
Finally the aim is to explore the effect of pre-operative HIIT exercise on physiological (e.g. cardiovascular fitness, body composition, metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) endpoints relative to usual care.
- Conditions
- Prostate Cancer
- Being tested
- High Intensity Interval Training, Usual Care Observational Control
- Keywords
- Prostate cancer, Localized, Exercise, Physical activity, Natural killer cells, Immune cells
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
Supervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes. Patients will perform a test of maximum cardio-respiratory (VO2 peak test). Using the patient's individual wattmax, a personalized exercise program will be prescribed.
After a light warm-up, patients will perform 25 min of aerobic high intensity interval training on a stationary bicycle, intervals will consist of cycles of HI intervals with 120% of wattmax for 1 min followed by recovery for 3 min at 30% of wattmax. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.
Usual Care Observational ControlBehavioural
The reference group will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet.This includes information regarding smoking cessation and alcohol reduction and a physiotherapist consultation regarding pelvic floor exercises. This group is allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise program. This will be monitored by self-report.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | The HIIT-group will receive usual care plus a supervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes. Receives: Behavioral: High Intensity Interval Training |
| Usual Care Observational Control | Active comparator | Patients randomized to usual care control will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet. Receives: Behavioral: Usual Care Observational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in intratumoral Natural Killer (NK)-cell infiltration
Natural killer (NK)-cell infiltration will be quantified using histological analyses.
Measured: Primary prostate biopsies and up to 8 weeks
Secondary outcomes (27)
Tumor vessel morphology
Tumor vessel morphology will be evaluated using histological analyses.
Measured: Primary prostate biopsies and up to 8 weeks
Tumor-metabolism, - biology and signaling
Tumor samples will undergo proteomic analyzes in order to uncover potential upregulated biomarkers.
Measured: Primary prostate biopsies and up to 8 weeks
Changes in immune cells
Quantification of immune cells will be measured in blood samples by flowcytometry analyses.
Measured: Baseline and up to 8 weeks
Changes in epinephrine concentration
Concentrations of epinephrine will be measured in blood samples by radioimmunoassay analyses.
Measured: Baseline and up to 8 weeks
Changes in nor-epinephrine concentration
Concentrations of nor-epinephrine will be measured in blood samples by radioimmunoassay analyses.
Measured: Baseline and up to 8 weeks
Changes in IL-1 concentration
Concentrations of IL-1 (Interleukin 1) will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in IL- 2 concentration
Concentrations of IL-2 (Interleukin 2) will be measured in fasting blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in IL- 6 concentration
Concentrations of IL-6 (Interleukin 6) will be measured in fasting blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in IL- 8 concentration
Concentrations of IL-8 (Interleukin 8) will be measured in fasting blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in IL- 10 concentration
Concentrations of IL-10 (Interleukin 10) will be measured in fasting blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in IL- 15R alpha complex concentration
Concentrations of IL- 15Rα (IL- 15 receptor alpha) complex will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in Tumor Necrosis Factor alpha (TNFa) concentration
Concentrations of TNFa will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in Interferon Gamma (IFNγ) concentration
Concentrations of IFNγ will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: Baseline and up to 8 weeks
Changes in Plasma Total-Cholesterol concentrations
Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.
Measured: Baseline and up to 8 weeks
Changes in Plasma LDL-Cholesterol concentrations
Concentrations of LDL-cholesterol will be measured in fasting blood samples by standard laboratory methods
Measured: Baseline and up to 8 weeks
Changes in Plasma HDL-Cholesterol concentrations
Concentrations of HDL-cholesterol will be measured in fasting blood samples by standard laboratory methods
Measured: Baseline and up to 8 weeks
Changes in Plasma Triglyceride concentrations
Concentrations of triglycerides will be measured in fasting blood samples by standard laboratory methods
Measured: Baseline to and up to 8 weeks
Changes in HbA1C (fasting blood samples)
Concentrations of HbA1C will be measured in fasting blood samples by standard laboratory methods
Measured: Baseline and up to 8 weeks
Changes in insulin
Concentrations of Insulin will be measured in fasting blood samples by standard laboratory methods
Measured: Baseline and up to 8 weeks
Change in body composition
Body weight and anthropometrics (height, waist and hip circumference) will be assessed using standard procedures. Resting heart rate and blood pressure (Microlife, BPA100) will be determined in a supine position. Body composition (fat mass, bone mass and fat-free mass) and bone mineral density are analyzed by whole-body dual-energy X-ray absorptiometry (DXA) scan (Lunar, Lunar Corporation Madison, Wisconsin, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. Since the different chemical compounds in the body absorb the intensity of the X-rays differently, the scan allows for a valid determination of bone mass, fat mass and fat-free/bone-free mass
Measured: Baseline and up to 8 weeks
Change in VO2peak
The participants will undergo a maximal graded exercise test on a bicycle ergometer for evaluation of cardiovascular function and determination of the peak oxygen uptake (VO2peak). The test starts with a 5 min warm up at 70 watt (the watts may have to be adjusted to the individual fitness level). Warm up is immediately followed by a 20 watt increase every 1 min until exhaustion. Ventilation and expired gases will be measured during the test via an indirect calorimetric system, and heart rate will be assessed simultaneously.
Measured: Baseline and up to 8 weeks
Change in wattmax
The participants will undergo a maximal graded exercise test on a bicycle ergometer for evaluation of cardiovascular function and determination of the maximum watt (wattmax). The test starts with a 5 min warm up at 70 watt (the watts may have to be adjusted to the individual fitness level). Warm up is immediately followed by a 20 watt increase every 1 min until exhaustion. The maximum watt will be calculated.
Measured: Baseline and up to 8 weeks
Changes in patient-reported Quality of Life - FACT
Patient reported quality of life is measured by Functional Assessment of Cancer Treatment (FACT)
Measured: Baseline and up to 8 weeks
Changes in Sleep Quality
Patient reported sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI) questionaire.
Measured: Baseline up to 8 weeks
Changes in Anxiety and Depression
Patient reported Anxiety and Depression is measured by the Hospital Anxiety and Depression Scale (HADS).
Measured: Baseline up to 8 weeks
Changes in Physical Activity level
Patient reported physical activity is measured by the International Physical Activity Questionaire (IPAQ) - short form.
Measured: Baseline up to 8 weeks
T-cell infiltration
T-cell infiltration will be quantified using histological analyses.
Measured: Primary prostate biopsies from baseline and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sissal Sigmundsdóttir Djurhuus, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954783
- Sponsor's protocol ID
- H-16034670
- Acronym
- PRO-TEST
- Status last verified
- Dec 2019
- First submitted
- 28 Oct 2016
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Djurhuus SS, Simonsen C, Toft BG, Thomsen SN, Wielsoe S, Roder MA, Hasselager T, Ostergren PB, Jakobsen H, Pedersen BK, Hojman P, Brasso K, Christensen JF. Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. BJU Int. 2023 Jan;131(1):116-124. doi: 10.1111/bju.15842. Epub 2022 Jul 18.
PubMed 35753072
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Exercise Regimens on Intratumoral Natural Killer (NK) Cell Variability in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02954783
- Acronym / sponsor ID
- PRO-TEST / H-16034670
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Localized, Exercise, Physical activity, Natural killer cells, Immune cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and purpose: The purpose of this study is to investigate the effect of exercise on intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer undergoing radical prostatectomy.
The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural killer (NK)-cell infiltration in patients with localized prostate cancer, and that the infiltration is greater in patients performing High Intensity Interval Training compared to usual care controls.
Currently there is a lack of randomized controlled trials examining different types of exercise in patients with localized prostate cancer. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.
Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.
Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either High Intensity Interval Training (HIIT) exercise intervention or observational control receiving usual care from inclusion and until planned surgery (radical prostatectomy).
All patients will undergo assessments at inclusion (baseline) and at follow-up after the exercise intervention period (maximum 8 weeks) 3-5 days prior to surgery.
Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality of life by self-report questionnaires; fasting blood sample measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and inflammatory markers.
Biological tissue from tumor (primary prostate biopsies) will be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.
Detailed description
The purpose of this study is to investigate the effect of exercise on the variability of intratumoral Natural Killer (NK)-cell infiltration in tumor biopsies taken before and after an exercise intervention in patients randomized 2:1 to one of two study arms: I) High Intensity Interval Training (HIIT) (N=20) or II) usual care, prior to radical prostatectomy.
In addition to this the investigators wish to investigate the effect of HIIT exercise on the infiltration of other immune cells into the tumor, tumor vessel morphology, modulation of tumor-metabolism, -biology and signaling.
Finally the aim is to explore the effect of pre-operative HIIT exercise on physiological (e.g. cardiovascular fitness, body composition, metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) endpoints relative to usual care.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Behavioral: High Intensity Interval TrainingThe HIIT-group will receive usual care plus a supervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes. |
| Usual Care Observational Control | Active comparator | Behavioral: Usual Care Observational ControlPatients randomized to usual care control will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologically verified localized prostate cancer
- Eligible for curative radical prostatectomy
Key exclusion criteria (5 listed)
- Any other known malignancy requiring active treatment
- Performance status > 1
- Ongoing treatment with beta blockers
- Physical disabilities precluding physical testing and/or exercise
- Inability to read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingSupervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes. Patients will perform a test of maximum cardio-respiratory (VO2 peak test). Using the patient's individual wattmax, a personalized exercise program will be prescribed. After a light warm-up, patients will perform 25 min of aerobic high intensity interval training on a stationary bicycle, intervals will consist of cycles of HI intervals with 120% of wattmax for 1 min followed by recovery for 3 min at 30% of wattmax. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load. | Behavioural | High Intensity Interval Training |
| Usual Care Observational ControlThe reference group will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet.This includes information regarding smoking cessation and alcohol reduction and a physiotherapist consultation regarding pelvic floor exercises. This group is allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise program. This will be monitored by self-report. | Behavioural | Usual Care Observational Control |
Primary outcome
Variability in intratumoral Natural Killer (NK)-cell infiltration
Time frame: Primary prostate biopsies and up to 8 weeks
Natural killer (NK)-cell infiltration will be quantified using histological analyses.
27 secondary outcomes
Tumor vessel morphology
Time frame: Primary prostate biopsies and up to 8 weeks
Tumor-metabolism, - biology and signaling
Time frame: Primary prostate biopsies and up to 8 weeks
Changes in immune cells
Time frame: Baseline and up to 8 weeks
Changes in epinephrine concentration
Time frame: Baseline and up to 8 weeks
Changes in nor-epinephrine concentration
Time frame: Baseline and up to 8 weeks
Changes in IL-1 concentration
Time frame: Baseline and up to 8 weeks
Changes in IL- 2 concentration
Time frame: Baseline and up to 8 weeks
Changes in IL- 6 concentration
Time frame: Baseline and up to 8 weeks
Changes in IL- 8 concentration
Time frame: Baseline and up to 8 weeks
Changes in IL- 10 concentration
Time frame: Baseline and up to 8 weeks
Changes in IL- 15R alpha complex concentration
Time frame: Baseline and up to 8 weeks
Changes in Tumor Necrosis Factor alpha (TNFa) concentration
Time frame: Baseline and up to 8 weeks
Changes in Interferon Gamma (IFNγ) concentration
Time frame: Baseline and up to 8 weeks
Changes in Plasma Total-Cholesterol concentrations
Time frame: Baseline and up to 8 weeks
Changes in Plasma LDL-Cholesterol concentrations
Time frame: Baseline and up to 8 weeks
Changes in Plasma HDL-Cholesterol concentrations
Time frame: Baseline and up to 8 weeks
Changes in Plasma Triglyceride concentrations
Time frame: Baseline to and up to 8 weeks
Changes in HbA1C (fasting blood samples)
Time frame: Baseline and up to 8 weeks
Changes in insulin
Time frame: Baseline and up to 8 weeks
Change in body composition
Time frame: Baseline and up to 8 weeks
Change in VO2peak
Time frame: Baseline and up to 8 weeks
Change in wattmax
Time frame: Baseline and up to 8 weeks
Changes in patient-reported Quality of Life - FACT
Time frame: Baseline and up to 8 weeks
Changes in Sleep Quality
Time frame: Baseline up to 8 weeks
Changes in Anxiety and Depression
Time frame: Baseline up to 8 weeks
Changes in Physical Activity level
Time frame: Baseline up to 8 weeks
T-cell infiltration
Time frame: Primary prostate biopsies from baseline and up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Derived from this study: PubMed 35753072Djurhuus SS, Simonsen C, Toft BG, Thomsen SN, Wielsoe S, Roder MA, Hasselager T, Ostergren PB, Jakobsen H, Pedersen BK, Hojman P, Brasso K, Christensen JF. Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. BJU Int. 2023 Jan;131(1):116-124. doi: 10.1111/bju.15842. Epub 2022 Jul 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Prostate Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in intratumoral Natural Killer (NK)-cell infiltration (time frame: Primary prostate biopsies and up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02954783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.