Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00769548 |
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Recruitment Status :
Completed
First Posted : October 9, 2008
Last Update Posted : January 4, 2017
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RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: flutamide Drug: goserelin acetate Radiation: low-LET photon therapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1322 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | April 1995 |
| Actual Primary Completion Date : | April 2001 |
| Actual Study Completion Date : | December 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.
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Drug: flutamide
Drug used for TAS. Drug: goserelin acetate Drug used for TAS. Radiation: low-LET photon therapy radiation therapy
Other Name: radiation therapy |
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Experimental: Arm 2
Neoadjuvant TAS given 2 months before and during RT to the prostate only.
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Drug: flutamide
Drug used for TAS. Drug: goserelin acetate Drug used for TAS. Radiation: low-LET photon therapy radiation therapy
Other Name: radiation therapy |
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Experimental: Arm 3
RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
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Drug: flutamide
Drug used for TAS. Drug: goserelin acetate Drug used for TAS. Radiation: low-LET photon therapy radiation therapy
Other Name: radiation therapy |
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Experimental: Arm 4
RT to the prostate only followed by 4 months of TAS.
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Drug: flutamide
Drug used for TAS. Drug: goserelin acetate Drug used for TAS. Radiation: low-LET photon therapy radiation therapy
Other Name: radiation therapy |
- Progression-free survival (Arms 1, 3 vs. Arms 2, 4) [ Time Frame: From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
- Progression-free survival (Arms 1, 2 vs. Arms 3, 4) [ Time Frame: From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
- Local progression [ Time Frame: From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
- Distant metastasis [ Time Frame: From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
- Overall survival [ Time Frame: From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
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| Ages Eligible for Study: | up to 120 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769548
| Study Chair: | Mack Roach, MD | University of California, San Francisco |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00769548 |
| Other Study ID Numbers: |
RTOG-9413 CDR0000063822 |
| First Posted: | October 9, 2008 Key Record Dates |
| Last Update Posted: | January 4, 2017 |
| Last Verified: | December 2016 |
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adenocarcinoma of the prostate stage I prostate cancer stage IIB prostate cancer |
stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases |
Male Urogenital Diseases Goserelin Flutamide Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |