Prostate CancerPROST-INCT02181192
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
A study testing PET/CT, Instant Radiotherapy according to guidelines and Radiotherapy after achievement of PSA marginal value in people with Prostate Cancer and Recurrence, run by University of Erlangen-Nürnberg Medical School.
Trial summary
PSA-recurrence prostate carcinoma is associated with two general problems. 1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available. 2. There is no standard therapy proved by randomised clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Recurrence
- What is being tested?
- PET/CT, Instant Radiotherapy according to guidelines and Radiotherapy after achievement of PSA marginal value
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2020
- 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
- postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml
- prior irradiation
- comprehension of study protocol content and signed informed consent form
- minimum age 18 years
Who cannot join
- primary therapy of prostate carcinoma
- PSA value >= 1 ng/ml
- diagnosed distant metastases before randomisation (osseous or systemic)
- performed PET/CT before randomisation
- malignant slave tumor
- potent men that are not willing or are unable to apply consequent contraception
Show all 10Show fewer
- ongoing drug- and/or alcohol abuse
- patients that are not willing or able to cooperate according to protocol
- patients in care
- patients that are not able to understand German language
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
PSA-recurrence prostate carcinoma is associated with two general problems.
- Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
- There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value < 0.5 ng/ml according to german S3 guidelines is based on retrospective data.
These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
- Conditions
- Prostate Cancer, Recurrence
- Being tested
- PET/CT, Instant Radiotherapy according to guidelines, Radiotherapy after achievement of PSA marginal value
- Keywords
- biochemical recurrence, prostate carcinoma, prostate cancer, PSA, postoperative, radiotherapy, imaging diagnostic, PET/CT, social economic aspects, quality of life
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
PET/CT
Instant Radiotherapy according to guidelinesRadiation
Instant Radiotherapy according to guidelines
Radiotherapy after achievement of PSA marginal valueRadiation
Radiotherapy after achievement of PSA marginal value
| Study group | Role | What they receive |
|---|---|---|
| delayed radiotherapy | Experimental | PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging Receives: Device: PET/CT; Radiation: Radiotherapy after achievement of PSA marginal value |
| instant radiotherapy | Active comparator | Instant Radiotherapy according to guidelines Receives: Radiation: Instant Radiotherapy according to guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival according to PSA-value
Subjects in the control arm have an aftertreatment period of 5 years. Follow-up period of intervention arm ends after 3 to 5 years after radiotherapy. Duration depends on the surveillance period until marginal value is reached. This period is subtracted from maximum follow-up period of 5 years.
Measured: at the end of follow-up period of 4 years
Secondary outcomes (6)
frequency of PSA-persistence
Measured: at the end of therapy , an expected average of 6 weeks
frequency of changes in therapeutic strategies by additional diagnostics
Measured: at the end of therapy , an expected average of 6 weeks
analysis for radiation parameters, restricted to patients of initiating center
Measured: at the end of therapy , an expected average of 6 weeks
therapy and following costs for patients
Measured: time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years
overall survival
Measured: at the end of therapy , an expected average of 6 weeks
quality of life and side effects
Measured: time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJul 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
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 University of Erlangen-Nürnberg Medical SchoolThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annedore Strnad, Dr. MHBA, Principal investigator, Strahlenklinik, Universitätsklinikum ErlangenRainer Fietkau, Dr., Study director, Strahlenklinik, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181192
- Sponsor's protocol ID
- PROST-I
- Acronym
- PROST-I
- Status last verified
- Jul 2016
- First submitted
- 18 Feb 2014
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
- ClinicalTrials.gov ID
- NCT02181192
- Acronym / sponsor ID
- PROST-I / PROST-I
- Conditions
- Prostate Cancer, Recurrence
- Keywords
- biochemical recurrence, prostate carcinoma, prostate cancer, PSA, postoperative, radiotherapy, imaging diagnostic, PET/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jul 2017
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 3 Jul 2014 (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.
PSA-recurrence prostate carcinoma is associated with two general problems.
- Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
- There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value < 0.5 ng/ml according to german S3 guidelines is based on retrospective data.
These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed radiotherapy | Experimental | Device: PET/CT, Radiation: Radiotherapy after achievement of PSA marginal valuePET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging |
| instant radiotherapy | Active comparator | Radiation: Instant Radiotherapy according to guidelinesInstant Radiotherapy according to guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml
- prior irradiation
- comprehension of study protocol content and signed informed consent form
- minimum age 18 years
Key exclusion criteria (10 listed)
- primary therapy of prostate carcinoma
- PSA value >= 1 ng/ml
- diagnosed distant metastases before randomisation (osseous or systemic)
- performed PET/CT before randomisation
- malignant slave tumor
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 |
|---|---|---|
| PET/CTPET/CT | Device | delayed radiotherapy |
| Instant Radiotherapy according to guidelinesInstant Radiotherapy according to guidelines | Radiation | instant radiotherapy |
| Radiotherapy after achievement of PSA marginal valueRadiotherapy after achievement of PSA marginal value | Radiation | delayed radiotherapy |
Primary outcome
Disease-free survival according to PSA-value
Time frame: at the end of follow-up period of 4 years
Subjects in the control arm have an aftertreatment period of 5 years. Follow-up period of intervention arm ends after 3 to 5 years after radiotherapy. Duration depends on the surveillance period until marginal value is reached. This period is subtracted from maximum follow-up period of 5 years.
6 secondary outcomes
frequency of PSA-persistence
Time frame: at the end of therapy , an expected average of 6 weeks
frequency of changes in therapeutic strategies by additional diagnostics
Time frame: at the end of therapy , an expected average of 6 weeks
analysis for radiation parameters, restricted to patients of initiating center
Time frame: at the end of therapy , an expected average of 6 weeks
therapy and following costs for patients
Time frame: time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years
overall survival
Time frame: at the end of therapy , an expected average of 6 weeks
quality of life and side effects
Time frame: time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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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.
Annedore Strnad, Dr. MHBA principal investigator
Strahlenklinik, Universitätsklinikum Erlangen
Rainer Fietkau, Dr. study director
Strahlenklinik, Universitätsklinikum Erlangen
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT, Instant Radiotherapy according to guidelines and Radiotherapy after achievement of PSA marginal value in people with Prostate Cancer and Recurrence, run by University of Erlangen-Nürnberg Medical School.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annedore Strnad, Dr. MHBA (+49(0)9131 85 33968, annedore.strnad@uk.erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival according to PSA-value (time frame: at the end of follow-up period of 4 years). 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 1 Aug 2016.