Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer

NCT ID: NCT00394511

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1988-08-31

Brief Summary

Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

Detailed Description

OBJECTIVES:

I. Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs. no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C (T3 N0 M0) adenocarcinoma of the prostate.

II. Determine the qualitative and quantitative toxicities associated with this adjuvant therapy.

OUTLINE: Randomized study. Randomization takes place when the patient is physically able to begin treatment, any time within 16 weeks after surgery.

Arm I: Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.

Arm II: No further treatment.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.

Group Type: EXPERIMENTAL

low-LET photon therapy

Intervention Type: PROCEDURE

Arm II

No further treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

low-LET photon therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• At least 1 of the following on pathologic examination:

• Presence of cancer in the seminal vesicles
• Evidence of cancer at the inked surgical margin of the prostate
• Extension of tumor beyond the prostatic capsule
• Negative preoperative metastatic survey within 6 months prior to registration, including the following:

• Normal bone scan
• No palpable evidence of extraprostatic tumor extension
• Bilateral lymph node dissection histologically negative for cancer
• Nodal sampling not required with the following stage/biopsy specimen Gleason score/preoperative PSA:

• Stage T1a/2-6/<10 ng/ml
• Stage T1b-c/2-5/<10 ng/ml
• Stage T2a/2-6/<10 ng/ml
• Stage T2b/2-6/<6 ng/ml
• Stage T2c/2-6/<4 ng/ml
• Free from the following postoperative complications:

• Total urinary incontinence
• Intraoperative rectal injury
• persistent urinary extravasation
• Pelvic infection
• Concurrent registration on protocol SWOG-9205 (serum repository protocol) optional
• Concurrent registration on protocol SWOG-8994 (quality-of-life study) required of English-speaking and Spanish-speaking patients enrolled by SWOG

--Patient Characteristics--

• Age: Any age
• Performance status: SWOG 0-2
• Life expectancy: At least 2 years
• Hematopoietic:

• WBC at least institutional LLN
• Platelets at least institutional LLN
• Hepatic: SGOT no more than 2 x ULN
• Other: No second malignancy within 5 years except adequately treated nonmelanomatous skin cancer

--Prior Concurrent Therapy--

• Chemotherapy: No prior chemotherapy for prostate cancer
• Endocrine therapy: No more than 3 months of hormonal therapy prior to prostatectomy allowed
• Radiotherapy: No prior radiotherapy for prostate cancer
• Surgery: Radical prostatectomy and pelvic lymphadenectomy within 16 weeks prior to registration required

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

SWOG Cancer Research Network

NETWORK

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

North Central Cancer Treatment Group

NETWORK

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Thompson IM, Paradelo JC, Crawford ED, Coltman CA, Blumenstein B. An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing. Urology. 1994 Dec;44(6):804-11. doi: 10.1016/s0090-4295(94)80161-4. No abstract available.

Reference Type: BACKGROUND

PMID: 7985307 (View on PubMed)

Swanson GP, Thompson IM, Tangem C, et al.: Phase III randomized study of adjuvant radiation therapy versus observation in patients with pathologic T3 prostate cancer (SWOG 8794). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-1, S1, 2005.

Reference Type: RESULT

Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.

Reference Type: DERIVED

PMID: 17105795 (View on PubMed)

Other Identifiers

SWOG-8794

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-PR2

Identifier Type: -

Identifier Source: secondary_id

CLB-9493

Identifier Type: -

Identifier Source: secondary_id

EST-9887

Identifier Type: -

Identifier Source: secondary_id

NCCTG-895251

Identifier Type: -

Identifier Source: secondary_id

RTOG-9019

Identifier Type: -

Identifier Source: secondary_id

INT-0086

Identifier Type: -

Identifier Source: secondary_id

CDR0000075112

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02483

Identifier Type: -

Identifier Source: org_study_id