NCT02280356
Completed
Phase 2
Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
ConditionsProstate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 45
- Locations
- 6
- Primary Endpoint
- Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
- •Pathologically-proven diagnosis of prostate adenocarcinoma
- •PSA 10-20ng/mL or
- •Gleason =7 or
- •Clinical stage T2b/c
- •Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
- •Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
- •International Prostate Symptom Score ≤15
Exclusion Criteria
- •Prior prostate surgery (including TURP)
- •Prior history of chronic prostatitis or urethral stricture
- •Inflammatory bowel disease
- •Prior history of pelvic radiotherapy
- •Unable to give informed consent
- •Metastatic disease.
Outcomes
Primary Outcomes
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
Time Frame: 12 months
Participants with Urinary Toxicity Assessed by CTCAE v4.0 at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.
Secondary Outcomes
- Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months(12 months)
Study Sites (6)
Loading locations...
Similar Trials
Recruiting
Phase 2
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer PatientsBreast CancerRadiotherapy Side EffectNCT05762900Cancer Institute and Hospital, Chinese Academy of Medical Sciences65
Active, not recruiting
Phase 1
Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)Prostate CancerNCT03269422Memorial Sloan Kettering Cancer Center35
Recruiting
Not Applicable
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate CancerProstate CancerProstate AdenocarcinomaLocalized Prostate CarcinomaNCT06518226UMC Utrecht160
Recruiting
Not Applicable
Radical Hypofractionated Radiotherapy for Localized Prostate CancerLocalized Prostate CancerNCT06325774Changhai Hospital20
Active, not recruiting
Phase 1
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate CancerProstate CancerAdenocarcinomaNCT00911118Memorial Sloan Kettering Cancer Center120