Clinical trial · Interventional
Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
NCT02229734CI-TRIAL-00052099FASTR-2completedPhase 2ClinicalTrials.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)
This study will explore the combination of a stereotactic body radiation therapy (SBRT) approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for older men with high risk prostate cancer, or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy. The purpose of this study is to examine the safety of a shorter course of radiation treatment combined wtih androgen deprivation therapy.
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 |
|---|---|---|---|
| Androgen Suppression | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation plus Androgen Supression
- description
- Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months
- interventionNames
- Radiation: Radiation
- Drug: Androgen Suppression
Primary outcomes (1)
- measure
- Genitourinary and Gastrointestinal Toxicity at 1 year
- timeFrame
- Year 1 of follow-up
- description
- Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
Secondary outcomes (4)
- measure
- Disease Free Survival at 3 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * High risk prostate cancer * Has had multidisciplinary consultation with radiation oncologist and urologist * Age \>70 or refuses standard treatment * No evidence of extra-prostatic disease on screening bone scan and 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 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 * patients on androgen deprivation therapy \> 2 months prior to study enrolment
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