MDACC Study Summary 2007-0302

Study Summary
No. 2007-0302:.......Prostate......Deborah A. Kuban......Radiation Oncology

Study Summary Title



Study Summary Number:	2007-0302

Study Title:	A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer

Physician

New Patient Referral



Name:	Deborah A. Kuban	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-7382 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	3 months after treatment, 6 months after treatment, then every 6 months until year 2 and yearly in years 3, 4 and 5.

Treatment Agents:	Questionnaire	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.

Study Objectives / Outcomes

To measure and compare health-related quality of life after treatment or management for the modalities offered as primary therapy for prostate cancer at MD Anderson Cancer Center.

Study Status Information



Study Activation / Registration Date:	11/14/2007

IRB Review and Approval Date:	11/14/2007

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Primary treatment at MD Anderson for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy, photon external beam radiation, photon external beam radiation with hormone therapy, proton radiation, radioisotopic implant, cryotherapy, or active surveillance.

2) Neoadjuvant, concurrent and adjuvant androgen ablation in conjunction with photon external beam radiation is allowed if not greater than 6 months total duration. Hormone therapy will be given as an LHRH agonist with or without an antiandrogen.

3) Pathologic diagnosis of prostate adenocarcinoma

4) AJCC (VI) stage T1-T3b N0M0

5) Ability to read, write, and fill out the self-survey questionnaires

6) Patients may be simultaneously enrolled on other MD Anderson treatment or laboratory protocols. The EPIC Survey will be used for both this protocol and for protocol 2007-0209 such that patients enrolled on both protocols will complete only one document at each survey point. Simultaneous enrollment on other survey protocols will be handled in a similar manner.

Exclusion Criteria:

1) Histology other than adenocarcinoma

2) Stage T4, nodal or distant metastasis

3) Prior treatment for prostate cancer except for neoadjuvant, concurrent and adjuvant androgen deprivation of 6 months or less duration in patients treated with photon radiation. Hormone therapy in all other modalities is not allowed.

4) Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment

5) Treatment for another pelvic malignancy, to include surgery or radiation

6) Treatment for another malignancy with chemotherapy completed within one year or less of treatment for prostate cancer.

7) Inflammatory bowel disease (eg. Crohn's or Ulcerative Colitis)

8) Patients 18 years or younger.

Links

Registration Number: NCT00561444
Study Information on Clinical Trials Registry (clinicaltrials.gov)