Clinical trial · Interventional
Surveillance or Focal Therapy
Surveillance or Focal Therapy (SOFT) for Prostate Cancer
NCT07207902CI-TRIAL-00096300SOFTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with newly diagnosed low-intermediate risk prostate cancer often are not advised of all the options in an easy to understand way. This trial will show patients a 2 minute animated Explainer video to better understand their treatment options. Patients will choose their treatment choice (surveillance, focal therapy, or standard treatment option) and we will determine disease related anxiety and decision regret scores.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Explainer video | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Men with prostate cancer
- interventionNames
- Behavioral: Explainer video
Primary outcomes (1)
- measure
- Treatment choice
- timeFrame
- 12 months
- description
- Incidence of surveillance, focal therapy, or other treatment choice
Secondary outcomes (1)
- measure
- Decision regret and anxiety scale
- timeFrame
- 12 months
- description
- Anxiety and Decision Regret Score
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Gleason 3+3 (GG 1) or 3+4 (GG2) * ≤4 cores * T1c-T2 * Prostate \< 60cc * MRI non-focal or PIRADS 3-4 in peripheral gland * Absence of significant anterior disease Exclusion Criteria: * Anal stenosis * Prostatic calfcifations * Latex allergy * Gleason grade group 3-5 * Multifocal or anterior disease * Prostate \> 60 cc
References
Publications (0)
Data not yet available
No reference posted for this study.