Preoperative Radiation Therapy for High Risk Prostate Cancer

NCT01041326 | Completed Phase 1 DMC

• 1 other identifier: Pro00006510
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Conditions

Prostate Cancer

Keywords

prostatectomy; radiation; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• post-operative morbidity

  30 day

Secondary Outcomes (3)

• continence

  1 year

• erectile function

  1 year

• biochemical recurrence

  2 years

Study Arms (4)

Leve 1 Radiation

EXPERIMENTAL

Subjects in Group 1 will receive 39.6 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Radiation: Radiation; Procedure: Radical Prostatectomy

Level 2 Radiation

EXPERIMENTAL

Subjects in Group 2 will receive 45 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Radiation: Radiation; Procedure: Radical Prostatectomy

Level 3 Radiation

EXPERIMENTAL

Subjects in Group 3 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Radiation: Radiation; Procedure: Radical Prostatectomy

Level 4 Radiation

EXPERIMENTAL

Subjects in Group 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 54 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Radiation: Radiation; Procedure: Radical Prostatectomy

Interventions

Radiation RADIATION

Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes

Leve 1 Radiation; Level 2 Radiation; Level 3 Radiation; Level 4 Radiation

Radical Prostatectomy PROCEDURE

Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy. If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy. This surgical procedure will be performed by one of the standard accepted approaches.

Leve 1 Radiation; Level 2 Radiation; Level 3 Radiation; Level 4 Radiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have
• biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA \> 20, B. Gleason Score (GS) \>/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
• a negative bone scan,
• be medically fit to undergo surgery as determined by treating urologist,
• age \> 18,
• KPS must be \>/= 80,
• no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
• no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
• Subjects must freely sign informed consent to enroll in the study.

You may not qualify if:

• prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
• prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
• Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
• Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
• Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
• History of prior pelvic radiation therapy.
• History of androgen deprivation therapy or chemotherapy.

Sponsors & Collaborators

• Duke University: lead
• Virginia Commonwealth University: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Koontz BF, Quaranta BP, Pura JA, Lee WR, Vujaskovic Z, Gerber L, Haake M, Anscher MS, Robertson CN, Polascik TJ, Moul JW. Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):88-93. doi: 10.1016/j.ijrobp.2013.05.014. Epub 2013 Jun 19.

  PMID: 23790772 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation

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)

Physical Phenomena

Study Officials

• Bridget F Koontz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: December 31, 2009
• Study Start: April 1, 2005
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

US (2)