Clinical trial · Interventional
FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer
NCT01439542CI-TRIAL-00034231FASTRterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Higher then expected Gr3 GU/GI toxicity
Summary
Brief summary (as posted)
The purpose of this study is to examine the safety of a shorter course of radiation treatments combined with one year of androgen deprivation therapy. The study will test this treatment in men with high risk prostate cancer who have significant other illnesses or circumstances such that conventional long term radiotherapy and hormone therapy is not recommended by their physician or desired by the patient.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luteinizing Hormone Releasing Hormone (LHRH) Agonist | Drug | — | UNRESOLVED |
| Stereotactic Body Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- interventionNames
- Radiation: Stereotactic Body Radiation
- Drug: Luteinizing Hormone Releasing Hormone (LHRH) Agonist
Primary outcomes (3)
- measure
- Toxicity
- timeFrame
- year 1 of follow-up
- description
- Assessment of late genitourinary and gastrointestinal toxicity at 1 year as assessed by the Common Toxicity Criteria
- measure
- Toxicity
- timeFrame
- year 2 of follow-up
- description
- Assessment of late genitourinary amd gastrointestinal toxicity at 2 years as assessed by the Common Toxicity Criteria
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * High risk prostate cancer: * clinical stage T3 (cT3) prostate cancer or * pre-treatment PSA \> 20 or * Gleason score\>8 on Trans-Rectal Ultrasound (TRUS) biopsy * Score of \> 3 on the Vulnerable Elderly Scale or refuses standard radiotherapy + androgen deprivation therapy * No evidence of extra-prostatic disease on screening bone scan and Computed Tomography (CT) scan (non-contrast CT used for CT simulation acceptable) * Signed written and voluntary informed consent provided. * Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures * Age ≥ 18 years Exclusion Criteria: * Patients not meeting the eligibility criteria * Prior pelvic radiotherapy or brachytherapy * Use of anti-coagulation (low molecular weight heparin or Coumadin) * History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis) * Previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
References
Publications (1)
- DERIVEDBauman G, Ferguson M, Lock M, Chen J, Ahmad B, Venkatesan VM, Sexton T, D'Souza D, Loblaw A, Warner A, Rodrigues G. A Phase 1/2 Trial of Brief Androgen Suppression and Stereotactic Radiation Therapy (FASTR) for High-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):856-62. doi: 10.1016/j.ijrobp.2015.02.046. Epub 2015 Apr 30. PMID 25936597