Focal Therapy for Prostate Cancer

NCT01802307 | Withdrawn Phase 2 DMC

• 1 other identifier: HP-00054478
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the most common solid organ cancer among men and is the second leading cause of cancer death. In 2013 about 238,590 men will be diagnosed with prostate cancer and 29,720 men will die of the cancer. Overall, about 1 in 6 men will be diagnosed with prostate cancer in their lifetime, but only 1 in 36 men will die. Currently, there are over 2.5 million men in the US living with prostate cancer. Standard treatment for prostate cancer has involved either removal of the prostate (radical prostatectomy) or application of some type of energy to the entire prostate gland in order to kill all of the cells--usually with radiation or cryotherapy (freezing). Over the past decade, it has become apparent that while some men will benefit from treatment for prostate cancer, many will not. Particularly for men with a small amount of low-grade (not very aggressive) type of prostate cancer, the risk of death from this very slow-growing cancer is very low. However, the risk of harm from some of the treatments for prostate cancer is very high. Treatment for prostate cancer can cause erectile dysfunction, urinary leakage, difficulty urinating and overactive bladder and bowel symptoms. One strategy for men with low risk prostate cancer has been to avoid immediate treatment and wait until the cancer starts to grow. The risk of this strategy is that some men may not be able to be cured once the cancer starts to grow. In addition, men who are on this active surveillance protocol can become very nervous, fearing that the cancer will start to spread. A new strategy to avoid some of the treatment harms of prostate cancer while also attempting to avoid allowing the cancer to grow is called focal therapy. Many men with low-risk prostate cancer will have only a small piece of cancer within the prostate gland. These men may benefit from treating only this one area instead of the entire prostate. This will allow the physician to kill the cancer cells and to avoid some of the problems associated with treating the entire prostate. The purpose of this study is to investigate the use of focal, targeted treatment of prostate cancer, that is, to treat only the small area of cancer instead of the entire prostate. We hope to show that this strategy will reduce the amount of side effects without compromising cancer cure.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

Focal therapy; Brachytherapy; Active surveillance; low risk cancer

Outcome Measures

Primary Outcomes (1)

• Transrectal Ultrasound-guided prostate biopsy

  Annual prostate biopsy will determine oncological efficacy of treatment of the primary lesion. A standard 12 core biopsy will be performed with an additional 2 cores directed toward the area that was treated. Outcomes will be reported as 1) Presence/absence of cancer in the treated location and 2) Presence of new cancer lesions in other portions of the prostate.

  yearly up to 5 years

Secondary Outcomes (2)

• Erectile function

  every 3-6 months for 5 years

• Urinary function/bother

  every 3-6 months up to 5 years

Study Arms (1)

Focal Therapy

EXPERIMENTAL

Radiation: Brachytherapy

Interventions

Brachytherapy RADIATION

Also known as: Seeds

Focal Therapy

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age \>44
• Low risk Prostate Cancer (PSA \<10, Gleason 6)
• Low-volume intermediate risk prostate cancer (PSA \<15, Gleason 3+4=7)
• Organ confined disease

You may not qualify if:

• Metastatic Disease
• Palpable disease bilaterally
• Locally advanced disease either by digital rectal exam or MRI
• PSA \>10 (for age \<75)
• PSA \>15

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• Barret E, Ahallal Y, Sanchez-Salas R, Galiano M, Cosset JM, Validire P, Macek P, Durand M, Prapotnich D, Rozet F, Cathelineau X. Morbidity of focal therapy in the treatment of localized prostate cancer. Eur Urol. 2013 Apr;63(4):618-22. doi: 10.1016/j.eururo.2012.11.057. Epub 2012 Dec 13.

  PMID: 23265382 BACKGROUND

• Klotz L. Active surveillance for prostate cancer: overview and update. Curr Treat Options Oncol. 2013 Mar;14(1):97-108. doi: 10.1007/s11864-012-0221-5.

  PMID: 23318986 BACKGROUND

• Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.

  PMID: 22808955 BACKGROUND

• Suardi N, Capitanio U, Chun FK, Graefen M, Perrotte P, Schlomm T, Haese A, Huland H, Erbersdobler A, Montorsi F, Karakiewicz PI. Currently used criteria for active surveillance in men with low-risk prostate cancer: an analysis of pathologic features. Cancer. 2008 Oct 15;113(8):2068-72. doi: 10.1002/cncr.23827.

  PMID: 18792067 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Seeds

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; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• James F Borin, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Michael J Naslund, MD

  University of Maryland, College Park

  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: February 26, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)