Clinical trial · Interventional
Immediate Curative vs Conservative Treatment in Older Men With M0, 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hormone therapy | Drug | Hormone Therapy | ALIAS |
| initial observation | Other | — | UNRESOLVED |
| Radiotherapy or surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- immediate curative therapy
- description
- Patients randomized to the intervention arm will receive immediate curative therapy in the form of either radiotherapy to the prostate in combination with hormone therapy (ADT or monotherapy) or surgery (radical prostatectomy). Standard treatment in this arm is radiotherapy + hormone therapy. Surgery is reserved for patients with strong preferences against radiotherapy.
- interventionNames
- Radiation: Radiotherapy or surgery
- type
- ACTIVE_COMPARATOR
- label
- initial observation/ hormone therapy
- description
- Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.
- interventionNames
- Other: initial observation
- Drug: Hormone therapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDLoffeler S, Bertilsson H, Muller C, Aas K, Haugnes HS, Aksnessaether B, Pesonen M, Thon K, Tandstad T, Murtola T, Poulsen MH, Nordstrom T, Vigmostad MN, Ottosson F, Holmsten K, Christiansen O, Slaaen M, Haug ES, Storas AH, Asphaug L, Rannikko A, Brasso K; Scandinavian Prostate Cancer Group (SPCG) and the Norwegian Get-Randomized (GRand) Initiative. Protocol of a randomised, controlled trial comparing immediate curative therapy with conservative treatment in men aged >/=75 years with non-metastatic high-risk prostate cancer (SPCG 19/GRand-P). BJU Int. 2024 Jun;133(6):680-689. doi: 10.1111/bju.16314. Epub 2024 Mar 12. PMID 38469686