Clinical trial · Interventional
5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
- 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)
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
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 |
|---|---|---|---|
| Oligometastatic Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High dose rate brachytherapy | Radiation | — | UNRESOLVED |
| Hypofractionated external beam radiotherapy | Radiation | — | UNRESOLVED |
| Permanent seed implant | Radiation | — | UNRESOLVED |
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- standard
- description
- External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
- interventionNames
- Radiation: Hypofractionated external beam radiotherapy
- type
- EXPERIMENTAL
- label
- High dose rate brachytherapy
- description
- A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
- interventionNames
- Radiation: High dose rate brachytherapy
- type
- EXPERIMENTAL
- label
- Permanent seed implant brachytherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed study specific informed consent * European Cooperative Oncology Group performance status 0 to 2 * Histologically confirmed adenocarcinoma of the prostate * Any Tumor stage, any T, any N, M1 * No prior therapy for prostate cancer apart from androgen deprivation * Planned for long-term androgen deprivation therapy (greater than 9 months in duration) * Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study * For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size. Exclusion Criteria: * High metastatic burden defined as 5 or more bone metastases or visceral metastases * Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation * For Brachytherapy Arms =: Any prior Transurethral resection of prostate
References
Publications (0)
Data not yet available