Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: external beam radiation therapy; Radiation: brachytherapy; Behavioral: questionnaires

• Registration Number: NCT02280356
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-28
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Status Verified: 2023-01
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Results First Submitted: 2023-09-19
• Results First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Results First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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
• Age ≥18
• KPS≥70
• 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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiation therapy in combination with brachytherapy	external beam radiation therapy	Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate \& seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, \& treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) \& every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal \& sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
radiation therapy in combination with brachytherapy	questionnaires	Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate \& seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, \& treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) \& every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal \& sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
radiation therapy in combination with brachytherapy	brachytherapy	Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate \& seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, \& treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) \& every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal \& sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0	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 Outcome Measures

Name	Time	Method
Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months	12 months	The International Prostate Symptom Score/IPSS index is a seven item questionnaire that assesses urinary functioning, including urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale. Higher scores indicate more difficulty in urinary functioning. A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic. Scale range is 0-35. Total score is reported.

Trial Locations

Locations (6)

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau (Follow Up Only); 🇺🇸 Uniondale, New York, United States