Prostate CancerPROTECT-ZNCT01020604
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients
An observational study of Prostate Cancer and Obesity, run by AstraZeneca at 34 sites in Hungary.
Trial summary
The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after 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, Obesity
- How many people
- 1,376 participants
- Where
- 34 sitesHungary
- Study dates
- Nov 2009to Mar 2013
- Phase
- Observational
- 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
Study population: Adult men treated by adjuvant goserelin therapy for at least 1 month after primary (curative) therapy of histologically proven, prostate cancer
Who may be able to join
- Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy
Who cannot join
- -Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Hungary34 sites
Research Site
Baja
Research Site
Barcs
Research Site
Békés
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Csongrád
Research Site
Debrecen
Research Site
Dunaharaszti
Research Site
Dunaújváros
Research Site
Győr
Research Site
Gyula
Research Site
Helvécia
Research Site
Jászberény
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Kiskunhalas
Research Site
Kőszárhegy
Research Site
Makó
Research Site
Miskolc
Research Site
Nagyvenyim
Research Site
Nyíregyháza
Research Site
Nyírpazony
Research Site
Orosháza
Research Site
Pápa
Research Site
Pécs
Research Site
Salgótarján
Research Site
Szeged
Research Site
Székesfehérvár
Research Site
Szekszárd
Research Site
Szentendre
Research Site
Szolnok
Research Site
Szombathely
Research Site
Tiszaföldvár
Research Site
Veszprém
About this study
Official title: PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients Assessment of the Correlation Between Body Mass Index and Recurrence Among Zoladex Treated Prostate Cancer Patients
The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. Other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. Limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. Primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. Secondary: to determine the Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
- Conditions
- Prostate Cancer, Obesity
- Keywords
- BMI, Prostate cancer, Recurrence
- Medical subject headings
- Prostatic Neoplasms, Obesity, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Measured: Every 3 months
Secondary outcomes (1)
Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,376 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Istvan Buzogany, Principal investigator, Budapest City's Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020604
- Sponsor's protocol ID
- NIS-OHU-ZOL-2009/1
- Acronym
- PROTECT-Z
- Status last verified
- Apr 2013
- First submitted
- 20 Nov 2009
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients Assessment of the Correlation Between Body Mass Index and Recurrence Among Zoladex Treated Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT01020604
- Acronym / sponsor ID
- PROTECT-Z / NIS-OHU-ZOL-2009/1
- Conditions
- Prostate Cancer, Obesity
- Keywords
- BMI, Prostate cancer, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,376 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Nov 2009 (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.
The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. Other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. Limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. Primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. Secondary: to determine the Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men treated by adjuvant goserelin therapy for at least 1 month after primary (curative) therapy of histologically proven, prostate cancer
Key inclusion criteria (1 listed)
- Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy
Key exclusion criteria (1 listed)
- -Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Time frame: Every 3 months
1 secondary outcome
Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
Time frame: Every 3 months
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 30 Apr 2013.
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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.
Istvan Buzogany principal investigator
Budapest City's Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Obesity, run by AstraZeneca at 34 sites in Hungary.
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 1 inclusion and 1 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 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Hungary. 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?
Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. (time frame: Every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2013.