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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

NCTNCT00002597 (opens ClinicalTrials.gov in a new tab)Other idRTOG-9408Other idCDR0000063821
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,028 participants (actual)
Sponsor
Radiation Therapy Oncology Group · Network
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Oct 1994
Primary completion
Jul 2011
Completion
14 May 2018
First posted
27 Feb 2004 (estimated)
Last update posted
14 Jun 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
19952000200520102015
  1. Ph 3

    Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

    NCT00002597

    Oct 1994 to 14 May 2018

Registry summary

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

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.

Interventions

  • flutamideDrug
  • ZoladexDrug
  • LupronDrug
  • radiation therapyRadiation

Arms2

  • Experimental

    Neoadjuvant TAS + RT

    Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.

  • Other

    Radiation therapy alone

    Radiation therapy alone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Overall Survival Rate (10-year)

    Time frame · From date of randomization to 10 years

    Registry description

    Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.

Secondary outcomes(8)

  1. Disease-specific Survival Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.

  2. Local Progression Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.

  3. Distant Failure Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.

  4. Biochemical Failure Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of \>2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.

  5. Clinical Relapse Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.

  6. Second Biochemical Relapse Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions.

  7. Disease-free Survival Rate (10 Years)

    Time frame · From registration to 10 years

    Registry description

    Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method.

  8. Positive Re-biopsy Rate at Two Years

    Time frame · From registration to two years

    Registry description

    The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.

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 date of randomization to 10 years

Overall Survival Rate (10-year)

GroupValue (percentage of patients)
Hormone Therapy + Radiation Therapy61.9
Radiation Therapy Alone56.8
Secondary and other outcome results(7)
Secondary outcomeNumber· From registration to 10 years

Disease-specific Survival Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy95.7
Radiation Therapy Alone92.6
Secondary outcomeNumber· From registration to 10 years

Local Progression Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy10.9
Radiation Therapy Alone16.1
Secondary outcomeNumber· From registration to 10 years

Distant Failure Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy5.5
Radiation Therapy Alone8.0
Secondary outcomeNumber· From registration to 10 years

Biochemical Failure Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy26.3
Radiation Therapy Alone41.1
Secondary outcomeNumber· From registration to 10 years

Clinical Relapse Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy15.0
Radiation Therapy Alone21.7
Secondary outcomeNumber· From registration to 10 years

Second Biochemical Relapse Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy2.7
Radiation Therapy Alone6.1
Secondary outcomeNumber· From registration to 10 years

Disease-free Survival Rate (10 Years)

GroupValue (percentage of participants)
Hormone Therapy + Radiation Therapy51.7
Radiation Therapy Alone39.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Neoadjuvant TAS 2 Months Before and During RTNeoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy–33 / 1003975 / 1003
Radiation Therapy AloneRadiation therapy alone–16 / 1003955 / 1003

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2022

Corrected

Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial.

Jones et al. 2022International journal of radiation oncology, biology, physicscited by 38

PMID 34481017PMC8748315DOI 10.1016/j.ijrobp.2021.08.031PUB-34481017

Rights unknown
Source linkRead the notice

Other registry references

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

  • ResultJones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. doi: 10.1056/NEJMoa1012348. PMID 21751904
  • ResultMcGowan D, Hunt D, Jones C, et al.: Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: initial results of RTOG 94-08. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-6, 2010.
  • DerivedSpratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29. PMID 38320143

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b. * Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0). * Karnofsky performance status ≥ 70. * PSA is mandatory, must be ≤ 20) * No prior hormonal therapy, radiation or chemotherapy. * Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization. * Prior testosterone administration allowed if at least 90 days elapsed since last administration. * No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman. * Treatment begins within 21 days after randomization. * Patients signs a study-specific informed consent form. * Alanine Aminotransferase (ALT) within 2x upper normal limits. Exclusion criteria: * Stage T1a or ≥ T2c disease. * Lymph node involvement (N1 - N3). * Evidence of distant metastasis. (M1) * PSA \> 20. * Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy. * Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma. Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry. * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. * Karnofsky performance status of \< 70.

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