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

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