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Prostate CancerPhase 3NCT00769548

Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

A Phase 3 study testing flutamide, goserelin acetate and low-LET photon therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
flutamide, goserelin acetate and low-LET photon therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,322 participants
Where
No sites listed yet
Study dates
Apr 1995to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

About this study

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)

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.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
flutamide, goserelin acetate, low-LET photon therapy
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • flutamideDrug

    Drug used for TAS.

  • goserelin acetateDrug

    Drug used for TAS.

  • low-LET photon therapyRadiation

    Also called radiation therapy

    radiation therapy

Study groups in NCT00769548
Study groupRoleWhat they receive
Arm 1ExperimentalNeoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.
Receives: Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy
Arm 2ExperimentalNeoadjuvant TAS given 2 months before and during RT to the prostate only.
Receives: Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy
Arm 3ExperimentalRT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
Receives: Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy
Arm 4ExperimentalRT to the prostate only followed by 4 months of TAS.
Receives: Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (Arms 1, 3 vs. Arms 2, 4)

    Measured: 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.

Secondary outcomes (4)

  1. Progression-free survival (Arms 1, 2 vs. Arms 3, 4)

    Measured: 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.

  2. Local progression

    Measured: From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

  3. Distant metastasis

    Measured: From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

  4. Overall survival

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2008 (estimated)
  2. Study startApr 1995
  3. Primary completionApr 2001
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769548
Sponsor's protocol ID
RTOG-9413
Other IDs
CDR0000063822
Status last verified
Dec 2016
First submitted
8 Oct 2008
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Du KL, Bae K, Movsas B, Yan Y, Bryan C, Bruner DW. Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer. 2012 Jun;20(6):1317-25. doi: 10.1007/s00520-011-1219-4. Epub 2011 Jul 1.

    PubMed 21720747

  • Hamstra DA, Bae K, Pilepich MV, Hanks GE, Grignon DJ, McGowan DG, Roach M, Lawton C, Lee RJ, Sandler H. Older age predicts decreased metastasis and prostate cancer-specific death for men treated with radiation therapy: meta-analysis of radiation therapy oncology group trials. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1293-301. doi: 10.1016/j.ijrobp.2010.07.2004. Epub 2011 Mar 31.

    PubMed 21458924

  • Rodrigues G, Bae K, Roach M, Lawton C, Donnelly B, Grignon D, Hanks G, Porter A, Lepor H, Sandler H. Impact of ultrahigh baseline PSA levels on biochemical and clinical outcomes in two Radiation Therapy Oncology Group prostate clinical trials. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):445-52. doi: 10.1016/j.ijrobp.2010.02.034. Epub 2010 Aug 24.

    PubMed 20615632

  • Roach M 3rd, Bae K, Lawton C, Donnelly BJ, Grignon D, Hanks GE, Porter A, Lepor H, Venketesan V, Sandler H. Baseline serum testosterone in men treated with androgen deprivation therapy and radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Dec 1;78(5):1314-22. doi: 10.1016/j.ijrobp.2009.09.073. Epub 2010 Apr 8.

    PubMed 20378270

  • Millar J, Boyd R, Sutherland J. An update of the phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: updated analysis of RTOG 94-13, with emphasis on unexpected hormone/radiation interactions: in regard to Lawton et al. (Int J Radiat Oncol Biol Phys 2007;69:646-655.). Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):316; author reply 316. doi: 10.1016/j.ijrobp.2008.01.009. No abstract available.

    PubMed 18406900

  • Williams S, Wiltshire K. Updated analysis of RTOG 94-13: in regard to Lawton et al. (Int J Radiat Oncol Biol Phys 2007;69:646-655). Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):315; author reply 315-6. doi: 10.1016/j.ijrobp.2008.01.021. No abstract available.

    PubMed 18406897

  • Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007.

  • Pan CC, Bae K, Hanks GE, et al.: Comparison of two types of biochemical failures within the ASTRO and Phoenix Consensus definitions in patients treated on RTOG 92-02 and 94-13. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2196, S318, 2006.

  • Roach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006.

  • Ganswindt U, Paulsen F, Corvin S, Eichhorn K, Glocker S, Hundt I, Birkner M, Alber M, Anastasiadis A, Stenzl A, Bares R, Budach W, Bamberg M, Belka C. Intensity modulated radiotherapy for high risk prostate cancer based on sentinel node SPECT imaging for target volume definition. BMC Cancer. 2005 Jul 28;5:91. doi: 10.1186/1471-2407-5-91.

    PubMed 16048656

  • Johnke RM, Edwards JM, Evans MJ, Nangami GN, Bakken NT, Kilburn JM, Lee TK, Allison RR, Karlsson UL, Arastu HH. Circulating cytokine levels in prostate cancer patients undergoing radiation therapy: influence of neoadjuvant total androgen suppression. In Vivo. 2009 Sep-Oct;23(5):827-33.

    PubMed 19779119

  • Roach M 3rd. The role of PSA in the radiotherapy of prostate cancer. Oncology (Williston Park). 1996 Aug;10(8):1143-53; discussion 1154-61.

    PubMed 8869957

  • Lawton CA, DeSilvio M, Roach M 3rd, Uhl V, Kirsch R, Seider M, Rotman M, Jones C, Asbell S, Valicenti R, Hahn S, Thomas CR Jr. An update of the phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: updated analysis of RTOG 94-13, with emphasis on unexpected hormone/radiation interactions. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):646-55. doi: 10.1016/j.ijrobp.2007.04.003. Epub 2007 May 24.

    PubMed 17531401

  • Taussky D, Bae K, Bahary JP, Roach M 3rd, Lawton CA, Shipley WU, Sandler HM. Does timing of androgen deprivation influence radiation-induced toxicity? A secondary analysis of radiation therapy oncology group protocol 9413. Urology. 2008 Nov;72(5):1125-9. doi: 10.1016/j.urology.2007.11.067. Epub 2008 Mar 7.

    PubMed 18314175

  • Roach M 3rd, DeSilvio M, Valicenti R, Grignon D, Asbell SO, Lawton C, Thomas CR Jr, Shipley WU. Whole-pelvis, "mini-pelvis," or prostate-only external beam radiotherapy after neoadjuvant and concurrent hormonal therapy in patients treated in the Radiation Therapy Oncology Group 9413 trial. Int J Radiat Oncol Biol Phys. 2006 Nov 1;66(3):647-53. doi: 10.1016/j.ijrobp.2006.05.074.

    PubMed 17011443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing flutamide, goserelin acetate and low-LET photon therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00769548, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.

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