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A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer


OBJECTIVES:

Primary

- To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of
external-beam radiotherapy) as definitive treatment for patients with intermediate-risk
prostate cancer.

- To assess acceptable toxicity, defined as treatment related toxicity (urinary and
rectal), no worse than that seen by patients treated with conventional therapy (grade 3
urinary toxicity < 10% and grade 3 rectal toxicity < 10%).

Secondary

- To achieve adequate dosimetric coverage of the prostate comparable to current
standards.

- To assess the effect of treatment on sexual function.

OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.

Patients complete bladder, bowel, sexual function, and quality of life questionnaires,
including the International Index of Erectile Function (IIEF) questionnaire, the
International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life
questionnaire at baseline and then at every follow-up visit.

After completion of study treatment, patients are followed every 3 months for 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following
criteria:

- PSA 10-20 ng/mL

- Gleason score ≥ 7

- Stage ≥ T2b AND < T3

- Less than 20% risk of seminal vesicle involvement or lymph node involved based upon
the Kattan nomogram (pre-treatment risk with IMRT)

- Prostate size < 60 cc by MRI or CT imaging

- International Prostate Symptom Score Index ≤ 15

Exclusion criteria:

- Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic
adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)

- Suspected extracapsular disease will not be considered an exclusion criteria

- PSA > 20 ng/mL

- Presence of distant metastases

PATIENT CHARACTERISTICS:

- WBC ≥ 3,500/mm³

- Platelet count ≥ 75,000/mm³

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 1.5 mg/dL

- Liver function tests ≤ 1.5 times normal

- INR ≤ 2.5

- Able to complete quality of life questionnaires

- Able to give informed consent

- No active perineal infections

- No history of urethral stricture

- No prior history of pelvic malignancy

- No prior history of lymphoma disease, ulcerative colitis, or anal fissures

- No contraindications to general anesthesia

- No pacemaker

PRIOR CONCURRENT THERAPY:

- No prior transurethral resection of the prostate

- No prior pelvic radiotherapy

- No prior treatment for prostate cancer except for hormone therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Outcome Time Frame:

At scheduled 3 month intervals for one year

Safety Issue:

No

Principal Investigator

Josh Yamada, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

07-120

NCT ID:

NCT00573833

Start Date:

November 2007

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021