NCT05448547 Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
| NCT ID | NCT05448547 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sven Löffeler |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 980 participants |
| Start Date | 2022-11-04 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 980 participants in total. It began in 2022-11-04 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (\>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.
Eligibility Criteria
Inclusion Criteria: 1. Participant must be 75 years of age or older, at the time of signing the informed consent. 2. Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score \>14, or reversibly frail; miniCOGTM: score \>2) And who have PCa (diagnosed ≤6 months) with one or both of the following features: * Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5) * Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study) * Able to read, understand and fill in HRQoL questionnaires (PROMS) 3. Male 4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Medical Conditions 1. Dementia (unable to consent) Prior/Concomitant Therapy 2. Prior radiation to the pelvis 3. Hormone therapy \>3 months prior to randomization Diagnostic assessments 4. Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board). 5. Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board). Other Exclusions 6. Disabled or severe comorbidity (identified by G8 screening) 7. Unable to read, understand or fill out HRQoL questionnaires (PROMS)
Contact & Investigator
Sven Loffeler, MD, PhD
PRINCIPAL INVESTIGATOR
The Hospital of Vestfold
Frequently Asked Questions
Who can join the NCT05448547 clinical trial?
This trial is open to male participants only, aged 75 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05448547 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 980 participants.
Is NCT05448547 currently recruiting?
Yes, NCT05448547 is actively recruiting participants. Contact the research team at sven.loffeler@siv.no for enrollment information.
Where is the NCT05448547 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Esbjerg, Denmark, Odense, Denmark, Helsinki, Finland and 11 additional locations.
Who is sponsoring the NCT05448547 clinical trial?
NCT05448547 is sponsored by Sven Löffeler. The principal investigator is Sven Loffeler, MD, PhD at The Hospital of Vestfold. The trial plans to enroll 980 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.