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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
NCI-2012-02483
NCT ID:
NCT00394511
Start Date:
August 1988
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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