Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma

NCT02181192 | Unknown

• 1 other identifier: PROST-I
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

PSA-recurrence prostate carcinoma is associated with two general problems.

1. 1.Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
2. 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.

Conditions

Prostate Cancer; Recurrence

Keywords

biochemical recurrence; prostate carcinoma; prostate cancer; PSA; postoperative; radiotherapy; imaging diagnostic; PET/CT; social economic aspects; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  at the end of follow-up period of 4 years

Secondary Outcomes (6)

• frequency of PSA-persistence

  at the end of therapy , an expected average of 6 weeks

• frequency of changes in therapeutic strategies by additional diagnostics

  at the end of therapy , an expected average of 6 weeks

• analysis for radiation parameters, restricted to patients of initiating center

  at the end of therapy , an expected average of 6 weeks

• therapy and following costs for patients

  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

  at the end of therapy , an expected average of 6 weeks

Study Arms (2)

delayed radiotherapy

EXPERIMENTAL

PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging

Device: PET/CT; Radiation: Radiotherapy after achievement of PSA marginal value

instant radiotherapy

ACTIVE COMPARATOR

Instant Radiotherapy according to guidelines

Radiation: Instant Radiotherapy according to guidelines

Interventions

PET/CT DEVICE

PET/CT

delayed radiotherapy

Instant Radiotherapy according to guidelines RADIATION

Instant Radiotherapy according to guidelines

instant radiotherapy

Radiotherapy after achievement of PSA marginal value RADIATION

Radiotherapy after achievement of PSA marginal value

delayed radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Annedore Strnad, Dr. MHBA

  Strahlenklinik, Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

• Rainer Fietkau, Dr.

  Strahlenklinik, Universitätsklinikum Erlangen

  STUDY DIRECTOR

Central Study Contacts

Annedore Strnad, Dr. MHBA

CONTACT

+49(0)9131 85 33968; annedore.strnad@uk.erlangen.de

Eva-Maria Weiss, Dr.

CONTACT

+49(0)9131 85 33968; eva-maria.weiss@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: July 3, 2014
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: August 1, 2016

Record last verified: 2016-07