Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer

NCT00032006 | Completed Phase 2

• 2 other identifiers: NCCTG-N0052CDR0000069248
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer. PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• quality of life

  Up to 10 years

Secondary Outcomes (4)

• Morbidity

  Up to 10 years

• Disease free survival

  Up to 10 years

• Disease specific survival

  Up to 10 years

• tumor recurrence

  Up to 10 years

Study Arms (1)

brachytherapy + radiation

EXPERIMENTAL

Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy. Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Radiation: brachytherapy; Radiation: radiation therapy

Interventions

brachytherapy RADIATION

brachytherapy + radiation

radiation therapy RADIATION

brachytherapy + radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed locally recurrent or persistent prostate adenocarcinoma * Locally recurrent disease * Prostate-specific antigen (PSA) no greater than 10 ng/mL * N0 and M0 (at time of initial diagnosis and at time of local recurrence) * Lymph nodes must be negative or will be negative after nodal sampling or dissection * More than 18 months after completion of prior external beam radiotherapy * Must have had 1 of the following disease characteristics prior to external beam radiotherapy: * T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL * T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL * T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL * Must have American Urological Association Symptom Index score no greater than 15 * Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL * No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 OR * ECOG 0-1 Life expectancy: * At least 5 years Other: * No persistent late intestinal or bladder toxicity grade 2 or greater * No other major medical or psychiatric illness that would preclude study * No metallic hip prosthesis * No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer * No other concurrent illness that would limit life expectancy * Suitable for spinal or general anesthesia * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy: * No prior chemotherapy for prostate cancer Endocrine therapy: * At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days Radiotherapy: * See Disease Characteristics * No prior external beam radiotherapy doses exceeding 71 Gy to the prostate * No prior radionuclide prostate brachytherapy Surgery: * No prior transurethral prostate resection * No prior prostatectomy or prostatic cryosurgery * No prior bilateral orchiectomy Other: * No concurrent participation in another medical research study for prostate cancer treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Thomas M. Pisansky, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (8)