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Preoperative Radiation Therapy for High Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Radiation

Radical Prostatectomy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostatectomy, radiation, neoadjuvant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Duke University Medical Center
Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Leve 1 Radiation

Level 2 Radiation

Level 3 Radiation

Level 4 Radiation

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

post-operative morbidity

Secondary Outcome Measures

continence

erectile function

biochemical recurrence

Full Information

NCT ID

NCT01041326

First Posted

December 30, 2009

Last Updated

July 16, 2013

Sponsor

Duke University

Collaborators

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT01041326

Brief Title

Preoperative Radiation Therapy for High Risk Prostate Cancer

Official Title

A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High Risk, Localized Carcinoma of the Prostate

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Virginia Commonwealth University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Prostate Cancer

Keywords

prostatectomy, radiation, neoadjuvant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Leve 1 Radiation

Arm Type

Experimental

Arm Description

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.

Arm Title

Level 2 Radiation

Arm Type

Experimental

Arm Description

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.

Arm Title

Level 3 Radiation

Arm Type

Experimental

Arm Description

Arm Title

Level 4 Radiation

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Radical Prostatectomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

post-operative morbidity

Time Frame

30 day

Secondary Outcome Measure Information:

Title

continence

Time Frame

1 year

Title

erectile function

Time Frame

1 year

Title

biochemical recurrence

Time Frame

2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bridget F Koontz, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23790772

Citation

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.

Results Reference

result

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Preoperative Radiation Therapy for High Risk Prostate Cancer

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