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Oligometastatic directed radiotherapy for patients with castration resistant prostate cancer.

Oligometastatic directed radiotherapy for patients with castration resistant prostate cancer. - OLYMPIAN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57227
Enrollment
35
Registered
2024-08-01
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

metastatic prostate cancer oligoprogressive castraction resistant prostate cancer

Interventions

All patients eligible for the trial will be discussed at the multidisciplinary urology tumor board. The choice for MDRT will be based on the localization and size of the metastases, the nearby organ

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Adenocarcinoma of the prostate. • mCRPC setting, with testosterone level = 18 years old. • Patient should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given. • Before patient registration, written informed consent must be given according to ICH/GCO and national/local regulations.

Exclusion criteria

Exclusion criteria: • Serum testosterone level > 50 ng/ml or > 1.7 nmol/l. • Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion). • Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma. • Local recurrence in the prostate after previous radiotherapy. • Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible. • Disorder precluding understanding of trial information or informed consent or signing informed consent. • Evidence of PSMA-negative disease.

Design outcomes

Primary

MeasureTime frame
• 6, 12-and 24-months NEST-FS. • 6- and 12- months rPFS.

Secondary

MeasureTime frame
• Quality of Life (QoL) evaluated using the EORTC QLQ-C30 for health related QoL and the EORTC PR-25 for prostate symptom specific QoL. • Acute and late toxicity reported using both physician-reported score (CTCAE v5) and patient-reported questionnaires (RTOG/EORTC). • Overall survival (OS).

Countries

Netherlands

Contacts

Public ContactS. Aluwini

Universitair Medisch Centrum Groningen

s.al-uwini@umcg.nl0625649975

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)