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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Prostate Cancer; Recurrence

Treatments: Radiation: Instant Radiotherapy according to guidelines; Device: PET/CT; Radiation: Radiotherapy after achievement of PSA marginal value

Study type: Interventional

Funder types: Other

Identifiers

NCT02181192

PROST-I

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

delayed radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy after achievement of PSA marginal value

Device: PET/CT

instant radiotherapy

Active Comparator group

Description:

Instant Radiotherapy according to guidelines

Treatment:

Radiation: Instant Radiotherapy according to guidelines