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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Behavioral: questionnaires; Radiation: brachytherapy; Radiation: external beam radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02280356

14-193

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

radiation therapy in combination with brachytherapy

Experimental group

Description:

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

Treatment:

Radiation: external beam radiation therapy

Behavioral: questionnaires

Radiation: brachytherapy