Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer

NCT00714753 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000600446P30CA015083MC065208-001451
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)

  Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade \>3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.

  From baseline to 3 years after registration

Secondary Outcomes (5)

• Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events

  From baseline to 5 years after registration

• Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)

  From baseline until the end of the first treatment

• Changes in Health-related Quality of Life Scores

  From baseline to 5 years after registration

• Freedom From Biochemical and Clinical Failure

  From baseline to 5 years after registration

• Freedom From Salvage Androgen Suppression Treatment

  From baseline to 5 years after registration

Study Arms (1)

Intervention Group

EXPERIMENTAL

Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.

Radiation: brachytherapy; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy; Radiation: intensity-modulated radiation therapy

Interventions

brachytherapy RADIATION

Intervention Group

hypofractionated radiation therapy RADIATION

Intervention Group

image-guided radiation therapy RADIATION

Intervention Group

intensity-modulated radiation therapy RADIATION

Intervention Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria: * Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA \< 10 ng/mL) * Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA \< 20 ng/mL OR T1-T2a, Gleason score 7, and PSA \< 10 ng/mL) * No known nodal (N0 or NX) or distant (M0 or MX) metastases * No pubic arch interference, as defined by either of the following: * Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension \< 4.3 cm * No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at A10°I beam's eye view * Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound * American Urological Association voiding symptom index ≤ 12 * Peak uroflow rate (Q\_max) ≥ 12 cc/second * Post-void ultrasound bladder residual volume ≤ 100 cc PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Life expectancy ≥ 5 years * WBC \> 2,000/μL * Platelet count \> 100,000/μL * PT \< 1.5 times upper limit of normal * No diabetes mellitus associated with vascular ulcers or wound-healing problems * No blood dyscrasias * No inflammatory bowel disease * No connective tissue disorder * No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or lymphomatous or hematological malignancy (except chronic lymphocytic leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years * No medical or psychiatric condition that would preclude giving informed consent or complying with study treatment * Able to undergo anesthesia PRIOR CONCURRENT THERAPY: * No prior transurethral resection of the prostate * No prior prostatic cryoablation or high-intensity focused ultrasound * No prior prostatectomy * No prior prostatic enucleation * No prior pelvic external beam radiotherapy * No prior radionuclide prostate brachytherapy * No prior hemi- or total hip arthroplasty * Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months prior to study entry and its total duration is ≤ 6 months * No concurrent anticoagulation therapy, including heparin or coumadin

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated

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)

Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Results Point of Contact

• Title: Thomas M. Pisansky, M.D.
• Organization: Mayo Clinic

Pisansky.Thomas@mayo.edu

Study Officials

• Thomas M. Pisansky, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 11, 2008
• First Posted: July 14, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 7, 2019
• Results First Posted: September 12, 2018

Record last verified: 2018-08

Locations

US (1)