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

National Cancer Institute (NCI) logo

National Cancer Institute (NCI)

Status and phase

Completed
Phase 3

Conditions

Prostate Cancer

Treatments

Procedure: low-LET photon therapy

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT00394511
CAN-NCIC-PR2
CLB-9493
NCCTG-895251
RTOG-9019
INT-0086
SWOG-8794
CDR0000075112 (Registry Identifier)
EST-9887
NCI-2012-02483

Details and patient eligibility

About

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.

Full 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.

Enrollment

408 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

408 participants in 2 patient groups

Arm I
Experimental group
Description:
Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
Treatment:
Procedure: low-LET photon therapy
Arm II
No Intervention group
Description:
No further treatment.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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