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A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)


Phase 3
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)


OBJECTIVES: I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and
whole-pelvic irradiation followed by a cone-down boost to the prostate improves
progression-free survival at 5 years by at least 10% compared to TAS and prostate-only
irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal
involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy
improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS
and radiotherapy. III. Compare treatments with regard to local control, time to distant
failure, and overall survival.

OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy.
Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the
whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II:
Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the
prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant
Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy
followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX.

PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Any stage
with an estimated risk of node involvement at least 15% (and therefore at significant risk
for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.:
GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and
PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest
pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL
PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may
need to be divided by a conversion factor of approximately 1.5 GS determination required
prior to entry No distant metastases No biopsy proven lymph node involvement Ineligible
for protocol RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for
this study)

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic:
Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not
specified Other: No major medical or psychiatric illness that would prevent completion of
treatment or interfere with follow-up No second malignancy within 5 years except
superficial nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since
finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since
surgical staging No radical surgery or cryosurgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mack Roach, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000063822

NCT ID:

NCT00769548

Start Date:

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

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