Comparing immediate curative treatment to conservative treatment for older men with high-risk prostate cancer
A Randomized, Open-label, Multicenter, Parallel Group Treatment, Phase 3, Two-arm Study to Measure the Effect on Overall Survival and Quality of Life of Immediate Curative Therapy Compared With Standard Conservative Treatment in Older Male Participants Aged ≥ 75 Years With Non-metastatic, High-risk Prostate Cancer
This study is testing whether immediate treatment like surgery or radiation is better than watchful waiting for older men with high-risk prostate cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 980 (estimated) |
| Ages | 75 Years and up |
| Sex | Male |
| Sponsor | The Hospital of Vestfold Academic / other |
| Drugs / interventions | radiation |
| Locations | 18 sites (Copenhagen and 17 other locations) |
| Trial ID | NCT05448547 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether immediate curative treatment, such as radiotherapy or surgery, is more effective than conservative treatment options for older men (75 years and older) with high-risk, non-metastatic prostate cancer. Participants will be randomly assigned to receive either immediate treatment or conservative management, allowing researchers to assess survival rates, quality of life, and cost-effectiveness. The study aims to address the lack of consensus on the best treatment approach for this demographic, which currently faces risks of both undertreatment and overtreatment. By evaluating the long-term benefits and side effects of immediate treatment, the trial seeks to provide clearer guidance for clinicians and patients alike.
Who should consider this trial
Good fit: Ideal candidates are men aged 75 years or older with high-risk, non-metastatic prostate cancer and who are capable of participating in health-related quality of life assessments.
Not a fit: Patients with low-risk prostate cancer or those who are not able to participate in the required assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence to optimize treatment strategies for older men with high-risk prostate cancer, potentially improving survival and quality of life.
How similar studies have performed: Other studies have shown varying success with similar treatment approaches, but this trial specifically addresses a gap in evidence for older patients, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Copenhagen and 17 other locations
- Rigshospital — Copenhagen, Denmark (Recruiting)
- Esbjerg and Grindsted Hospital — Esbjerg, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- Sunmøre Hospital Trust — Ålesund, Møre og Romsdal, Norway (Recruiting)
- Oslo University Hospital — Oslo, Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Rogaland, Norway (Recruiting)
- Sørlandet Hospital Trust — Kristiansand, Sørlandet, Norway (Recruiting)
- Telemark Hospital Trust — Skien, Telemark, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Trøndelag, Norway (Recruiting)
- Vestfold Hospital Trust (Hospital of Vestfold) — Tønsberg, Vestfold, Norway (Recruiting)
- Vestre Viken Hospital Trust — Drammen, Norway (Recruiting)
- Innlandet Hospital Trust — Hamar, Norway (Recruiting)
- Akerhus University Hospital — Lørenskog, Norway (Recruiting)
- University Hospital of Northern Norway — Tromsø, Norway (Recruiting)
- Capio Saint Göran's Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Sven Loffeler, MD, PhD — The Hospital of Vestfold
- Study coordinator: Sven Loffeler, MD, PhD
- Email: sven.loffeler@siv.no
- Phone: +4792235628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.