Phase 2 N=45 Treatment

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

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02280356 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0 — 33 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: external beam radiation therapy (Radiation); brachytherapy (Radiation); questionnaires (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0	33	—
SECONDARY Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months	5	—

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.

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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02280356). 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.