Clinical trial · Interventional

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

Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate

NCT00394511CI-TRIAL-00009417completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
low-LET photon therapy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I
description
Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
interventionNames
1. Procedure: low-LET photon therapy
type
NO_INTERVENTION
label
Arm II
description
No further treatment.

Primary outcomes (0)

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Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

BACKGROUNDThompson 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 7985307
RESULTSwanson 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.
DERIVEDThompson 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 17105795