Prostate Radiotherapy in Metastasized Disease In Accelerated Time

Prostate Radiotherapy in Metastasized Disease In Accelerated Time - PRIME-TIME

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040387

Enrollment

Registered

2026-05-21

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Definitive CT-based online-adaptive stereotactic radiotherapy of the prostate

total dose to the PTV: 35 Gy in 5 fractions (SD 7 Gy).

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • histologically confirmed prostate carcinoma with histological classification according to Gleason score and available PSA value (initial diagnosis < 3 months before study enrolment) • Stage IV prostate cancer • ECOG 0-2 • IPSS < 15 • Prostate volume < 80 cc • patient information and written consent • patient’s ability to consent

Exclusion criteria

Exclusion criteria: • Previous radiotherapy in the pelvis • Previous local therapy of the prostate • Simultaneous participation in another clinical study that could influence the results of the respective study • Extensive obstructive genitourinary symptoms

Design outcomes

Primary

Measure	Time frame
Occurrence of any genitourinary (GU) CTCAE toxicity = grade 2 within the first 12 weeks (exceeding baseline) or treatment related discontinuation of therapy.	—

Secondary

Measure	Time frame
• Treatment or Disease related mortality within 12 months after start of radiotherapy • Time to biochemical progression • Radiographic progression free survival (rPFS) • Cumulative incidence of any NCI CTCAE v5.0 gastrointestinal or genitourinary toxicity within the 12 months after start of radiotherapy • Biochemical progression free survival (bPFS) (PSA measurements quarterly until month 24, then every 6 months until month 60 via study center or urologist) • Overall survival (OS) after 5 years • Influence on quality of life (general (QLQ--C30) and prostate-specific (PR-25) 25)) at 6 weeks after RT start and week 12, months 6, 9, 12, 18, 24, 36, 48 and 60 • Analysis of planning and radiation data as well as imaging and quality assurance • Development of optimized workflows and principles for CT based online adaptive radiotherapy	—

Measure

Time frame

• Treatment or Disease related mortality within 12 months after start of radiotherapy • Time to biochemical progression • Radiographic progression free survival (rPFS) • Cumulative incidence of any NCI CTCAE v5.0 gastrointestinal or genitourinary toxicity within the 12 months after start of radiotherapy • Biochemical progression free survival (bPFS) (PSA measurements quarterly until month 24, then every 6 months until month 60 via study center or urologist) • Overall survival (OS) after 5 years • Influence on quality of life (general (QLQ--C30) and prostate-specific (PR-25) 25)) at 6 weeks after RT start and week 12, months 6, 9, 12, 18, 24, 36, 48 and 60 • Analysis of planning and radiation data as well as imaging and quality assurance • Development of optimized workflows and principles for CT based online adaptive radiotherapy

—

Countries

Germany

Contacts

Public ContactJakob Liermann

Universitätsklinikum Heidelberg, Klinik für RadioOnkologie und Strahlenhterapie

studienkoordination.rad@med.uni-heidelberg.de06221 56 34091

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026