Clinical trial · Interventional
Radiation and Androgen Ablation for Prostate Cancer
Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
NCT01517451CI-TRIAL-00102973completedPhase 1 / Phase 2Results postedClinicalTrials.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)
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating 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 |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy (ADT) | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation with Androgen Deprivation Therapy (ADT)
- description
- This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
- interventionNames
- Radiation: Radiation Therapy
- Drug: Androgen Deprivation Therapy (ADT)
Primary outcomes (1)
- measure
- Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
- timeFrame
- From consent up to 5 years post treatment completion
- description
- To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, locally confined adenocarcinoma of the prostate * Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7). * The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer. * Signed study-specific consent form prior to registration Exclusion Criteria: * Stage T3-4 disease. * Gleason 8 or higher score. * PSA \> 20 ng/ml. * IPSS (International Prostate Symptom Score) \> 15 * Clinical or Pathological Lymph node involvement (N1). * Evidence of distant metastases (M1). * Radical surgery for carcinoma of the prostate. * Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer. * Previous pelvic radiation therapy. * Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years. * History of inflammatory bowel disease. * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. * Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11 * Liver function tests (LFTs) greater than twice the upper limit of normal.
References
Publications (0)
Data not yet available
No reference posted for this study.