NCT00394511

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P50-P75 for phase_3 prostate-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1988

Completed
18.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

February 11, 2013

Status Verified

October 1, 2006

Enrollment Period

18.3 years

First QC Date

October 31, 2006

Last Update Submit

February 8, 2013

Conditions

Prostate Cancer

Study Arms (2)

Arm I

EXPERIMENTAL

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

Procedure: low-LET photon therapy

Arm II

NO INTERVENTION

No further treatment.

Interventions

low-LET photon therapyPROCEDURE
Arm I

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Pathologically documented Stage C (T3 N0 M0) adenocarcinoma of the prostate following radical prostatectomy and pelvic lymphadenectomy for clinical Stage A/B disease * Ineligible for SWOG protocols of higher priority * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 7985307BACKGROUND

  • 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.

    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.

    PMID: 17105795DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

August 1, 1988

Primary Completion

December 1, 2006

Last Updated

February 11, 2013

Record last verified: 2006-10