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

Prostate Cancer Clinical Trial

— PROST-I  

Official title:

Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02181192
• Other study ID #: PROST-I
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2014
• Last updated: July 29, 2016
• Start date: July 2017
• Est. completion date: July 2020

Study information

• Verified date: July 2016
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Annedore Strnad, Dr. MHBA
• Phone: +49(0)9131 85 33968
• Email: annedore.strnad[@]uk.erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Device:
• PET/CT
PET/CT

Radiation:
• Instant Radiotherapy according to guidelines
Instant Radiotherapy according to guidelines
• Radiotherapy after achievement of PSA marginal value
Radiotherapy after achievement of PSA marginal value

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	frequency of PSA-persistence		at the end of therapy , an expected average of 6 weeks	No
Secondary	frequency of changes in therapeutic strategies by additional diagnostics		at the end of therapy , an expected average of 6 weeks	No
Secondary	analysis for radiation parameters, restricted to patients of initiating center		at the end of therapy , an expected average of 6 weeks	No
Secondary	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	No
Secondary	overall survival		at the end of therapy , an expected average of 6 weeks	No
Secondary	quality of life and side effects		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	No