Trial · Interventional

CompletedPhase 3Results postedRegistry data

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

NCTNCT00004054Other idRTOG-9902Other idCDR0000067250

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Goserelin, does not test it. It appears in the description.
Names Leuprolide, does not test it. It appears in the description.
Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the description.

Overview

Status: Completed
Phase: Phase 3
Enrollment: 397 participants (actual)
Sponsor: Radiation Therapy Oncology Group · Network
Design: Randomized · Open label (no masking)
Countries: 2 countries
United States, Canada
Start: Jan 2000
Primary completion: Apr 2010
Completion: Nov 2013
First posted: 27 Jan 2003 (estimated)
Last update posted: 22 Oct 2020
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200020052010

Ph 3
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
NCT00004054
Jan 2000 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.

Interventions

bicalutamideDrug
estramustine phosphate sodiumDrug
etoposideDrug
flutamideDrug
paclitaxelDrug
Luteinizing hormone releasing hormone [LHRH] agonistDrug
Radiation therapyRadiation
warfarinDrug

Arms2

Experimental
Hormones and RT
Androgen suppression (AS) (Luteinizing hormone releasing hormone agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
Experimental
Hormones and RT plus Chemotherapy
AS (LHRH agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin \[Coumadin®\]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.

Primary outcomes1

Outcomes the sponsor listed as primary.

Overall Survival (5-year Rate Reported)
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.
Registry description
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.

Secondary outcomes(4)

Rate of Biochemical Failure at 5 Years
Time frame · From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Registry description
Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method.
Rate of Local Progression at 5 Years
Time frame · From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Registry description
Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method.
Rate of Distant Metastasis at Five Years
Time frame · From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Registry description
Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method.
Disease-free Survival Rate at 5 Years
Time frame · From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Registry description
Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 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.

Overall Survival (5-year Rate Reported)

Group	Value (percentage of participants)
Hormones and RT	84.9
Hormones and RT Plus Chemotherapy	87.2

Secondary and other outcome results(4)

Secondary outcomeNumber· From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.

Rate of Biochemical Failure at 5 Years

Group	Value (percentage of participants)
Hormones and RT	48.0
Hormones and RT Plus Chemotherapy	47.9

Secondary outcomeNumber· From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.

Rate of Local Progression at 5 Years

Group	Value (percentage of participants)
Hormones and RT	5.8
Hormones and RT Plus Chemotherapy	4.1

Secondary outcomeNumber· From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.

Rate of Distant Metastasis at Five Years

Group	Value (percentage of participants)
Hormones and RT	10.4
Hormones and RT Plus Chemotherapy	8.3

Secondary outcomeNumber· From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.

Disease-free Survival Rate at 5 Years

Group	Value (percentage of participants)
Hormones and RT	39.1
Hormones and RT Plus Chemotherapy	42.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Hormones and RTAS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT.	–	6 / 197	189 / 197
Hormones and RT Plus ChemotherapyAS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.	–	70 / 200	198 / 200

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultRosenthal SA, Bae K, Pienta KJ, Sobczak ML, Asbell SO, Rajan R, Kerlin KJ, Michalski JM, Sandler HM; Radiation Therapy Oncology Group Trial 9902. Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: preliminary toxicity analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):672-8. doi: 10.1016/j.ijrobp.2008.05.020. Epub 2008 Nov 5. PMID 18990504
ResultRosenthal SA, Hunt D, Sartor AO, Pienta KJ, Gomella L, Grignon D, Rajan R, Kerlin KJ, Jones CU, Dobelbower M, Shipley WU, Zeitzer K, Hamstra DA, Donavanik V, Rotman M, Hartford AC, Michalski J, Seider M, Kim H, Kuban DA, Moughan J, Sandler H. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902. Int J Radiat Oncol Biol Phys. 2015 Oct 1;93(2):294-302. doi: 10.1016/j.ijrobp.2015.05.024. Epub 2015 Jul 21. PMID 26209502
DerivedNguyen PL, Huang HR, Spratt DE, Davicioni E, Sandler HM, Shipley WU, Efstathiou JA, Simko JP, Pollack A, Dicker AP, Roach M, Rosenthal SA, Zeitzer KL, Mendez LC, Hartford AC, Hall WA, Desai AB, Rabinovitch RA, Peters CA, Rodgers JP, Tran P, Feng FY. Analysis of a Biopsy-Based Genomic Classifier in High-Risk Prostate Cancer: Meta-Analysis of the NRG Oncology/Radiation Therapy Oncology Group 9202, 9413, and 9902 Phase 3 Randomized Trials. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):521-529. doi: 10.1016/j.ijrobp.2022.12.035. Epub 2022 Dec 31. PMID 36596347

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

DISEASE CHARACTERISTICS: * Histologically proven prostate cancer at high risk for relapse as determined by either of the following: * Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage) * Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL * Negative lymph nodes * No metastatic disease PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Zubrod 0 or 1 Life expectancy: * Not specified Hematopoietic: * White blood cell (WBC) count of at least 3,000/mm\^3 * Platelet count at least 130,000/mm\^3 * Hemoglobin at least 11.4 g/dL Hepatic: * Aspartate aminotransferase (AST) no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 2.5 mg/dL Other: * No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer * No major medical or psychiatric illness that would preclude study participation * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 5 years since prior chemotherapy Endocrine therapy: * At least 60 days since prior finasteride for prostatic hypertrophy * At least 90 days since prior testosterone * No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer Radiotherapy: * No prior pelvic radiotherapy * No concurrent intensity-modulated radiotherapy Surgery: * No prior radical prostatectomy * No prior cryosurgery for prostate cancer * No prior orchiectomy

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