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Internal Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

questionnaire administration

quality-of-life assessment

brachytherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDR Brachytherapy

Arm Description

9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days

Outcomes

Primary Outcome Measures

Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity

Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity

Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity

urinary and rectal toxicity-see the adverse event tables

Secondary Outcome Measures

Full Information

NCT ID

NCT00573833

First Posted

December 13, 2007

Last Updated

September 19, 2017

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00573833

Brief Title

Internal Radiation Therapy in Treating Patients With Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HDR Brachytherapy

Arm Type

Experimental

Arm Description

9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

brachytherapy

Primary Outcome Measure Information:

Title

Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity

Description

Time Frame

At scheduled 3 month intervals for one year

Title

Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity

Description

urinary and rectal toxicity-see the adverse event tables

Time Frame

Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)

Other Pre-specified Outcome Measures:

Title

Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint

Description

Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)

Time Frame

week 12 reported

Title

Median International Prostate Symptom Total Score

Description

Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).

Time Frame

week 12 reported

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josh Yamada, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael J. Zelefsky, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sherri M. Donat, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marco Zaider, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mskcc.org/

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Internal Radiation Therapy in Treating Patients With Prostate Cancer

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