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Trial record 70 of 33581 for:    value

Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma (PROST-I)

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ClinicalTrials.gov Identifier: NCT02181192
Recruitment Status : Not yet recruiting
First Posted : July 3, 2014
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrence Device: PET/CT Radiation: Instant Radiotherapy according to guidelines Radiation: Radiotherapy after achievement of PSA marginal value Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
Study Start Date : July 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: delayed radiotherapy
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
Device: PET/CT
PET/CT

Radiation: Radiotherapy after achievement of PSA marginal value
Radiotherapy after achievement of PSA marginal value

Active Comparator: instant radiotherapy
Instant Radiotherapy according to guidelines
Radiation: Instant Radiotherapy according to guidelines
Instant Radiotherapy according to guidelines




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. frequency of PSA-persistence [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
  2. frequency of changes in therapeutic strategies by additional diagnostics [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
  3. analysis for radiation parameters, restricted to patients of initiating center [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
  4. 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 ]
  5. overall survival [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181192


Contacts
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Contact: Annedore Strnad, Dr. MHBA +49(0)9131 85 33968 annedore.strnad@uk.erlangen.de
Contact: Eva-Maria Weiss, Dr. +49(0)9131 85 33968 eva-maria.weiss@uk-erlangen.de

Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Annedore Strnad, Dr. MHBA Strahlenklinik, Universitätsklinikum Erlangen
Study Director: Rainer Fietkau, Dr. Strahlenklinik, Universitätsklinikum Erlangen

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02181192     History of Changes
Other Study ID Numbers: PROST-I
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Keywords provided by University of Erlangen-Nürnberg Medical School:
biochemical recurrence
prostate carcinoma
prostate cancer
PSA
postoperative
radiotherapy
imaging diagnostic
PET/CT
social economic aspects
quality of life
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes