Phase 2
N=45
Radiation and Androgen Ablation for Prostate Cancer
Adenocarcinoma of the Prostate
Bottom Line
View on ClinicalTrials.gov: NCT01517451 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Feb 2026
Primary outcome: Primary: Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT). — 0 progression events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Radiation Therapy (Radiation); Androgen Deprivation Therapy (ADT) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT). |
— | — |
| SECONDARY Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events |
4; 0 | — |
| SECONDARY Overall Survival Rate |
44 | — |
| SECONDARY Number of Patients Who Completed Blood Collection of Whole Blood for Future Research |
10 | — |
| SECONDARY Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS). |
7.32; 7.79; 7.91; 2.00; 6.82 | — |
| SECONDARY Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment |
15.3; 6.14; 7.16; 25.0; 6.79 | — |
| SECONDARY The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health |
34.7; 38.2; 100; 39.8 | — |
Summary
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01517451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.