Clinical trial · Interventional
Observation or Radical Treatment in Patients With Prostate Cancer
A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not meeting accrual target.
Summary
Brief summary (as posted)
RATIONALE: Sometimes prostate tumours may not need treatment until they progress. In this case, observation may be sufficient. Radical treatments, such as radical prostatectomy or radiation therapy, may be effective in treating prostate cancer when it is first diagnosed. It is not yet known whether active surveillance is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer. PURPOSE: This randomized phase III trial is studying active surveillance to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies | Procedure | — | UNRESOLVED |
| brachytherapy | Radiation | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Active Surveillance
- description
- Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
- type
- ACTIVE_COMPARATOR
- label
- Radical Intervention
- description
- Radical prostatectomy or radiotherapy based on patient and physician preference
- interventionNames
- Procedure: conventional surgery
- Radiation: brachytherapy
- Radiation: external beam radiation therapy
- Procedure: Biopsies
Primary outcomes (1)
- measure
- Disease-specific Survival
- timeFrame
- 5 years 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Diagnosed within 6 months prior to randomization * Patient has been classified as favorable risk as defined by the following: * Clinical stage T1b, T1c, T2a, or T2b at the time of diagnosis * Clinical (diagnostic biopsy) Gleason score ≤ 6 * PSA ≤ 10.0 ng/mL * Physical examination, rectal examination, and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis * Patient is a suitable candidate for radical prostatectomy or radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0, 1, or 2 * Patient has a minimum life expectancy of \> 10 years * In centers participating in the quality of life component of the study, the patient is able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French * No history of other malignancies, except adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years from study randomization PRIOR CONCURRENT THERAPY: * No previous treatment for prostate cancer, including surgery (excluding biopsy and TURP), radiotherapy, or androgen deprivation therapy for greater than 3 months * No planned androgen therapy except in the context of radical therapy
References
Publications (1)
- DERIVEDFung-Kee-Fung SD, Porten SP, Meng MV, Kuettel M. The role of active surveillance in the management of prostate cancer. J Natl Compr Canc Netw. 2013 Feb 1;11(2):183-7. doi: 10.6004/jnccn.2013.0026. PMID 23411385