Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy

NCT00175396 | Unknown Phase 3

• 1 other identifier: H04-60050
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare two similar treatments for patients diagnosed with prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy, which will prevent the production of the male hormone, testosterone, by the testicles, and pelvic external beam radiation therapy (EBRT) followed by a high-dose, conformal EBRT boost versus (Investigational Arm) hormone therapy and pelvic EBRT followed by a brachytherapy boost (implantation of radioactive iodine sources or "seeds" into the prostate). The hypothesis of this trial is that more patients may experience 5 year actuarial freedom from biochemical recurrence of their prostate cancer following treatment with the investigational arm. Biochemical failure is declared on the date when the post treatment prostate specific antigen (PSA) is \> 2 ng/mL above the lowest level previously recorded.

Conditions

Prostate Cancer

Keywords

ASCENDE-RT

Outcome Measures

Primary Outcomes (1)

• The primary end point of this trial is 5 year actuarial freedom from biochemical recurrence (5 year bNED) using the Houston definition of biochemical failure.

  5 years

Secondary Outcomes (1)

• This trial is also intended to determine overall survival, metastasis-free survival, pathological local control, incidence of acute and late side effects and complications associated with the treatment interventions, effect of the planned interventions.

  5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Procedure: Androgen suppression, radiotherapy

2

EXPERIMENTAL

Procedure: Androgen suppression, radiotherapy, iodine 125 brachytherapy

Interventions

Androgen suppression, radiotherapy PROCEDURE

Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by an external beam radiation boost lasting 3.2-4 weeks (32 Gy in 16 equal fractions).

Also known as: Androgen suppression: non-steroidal androgen (any of flutamide, nilutamide or bicalutamide (bicalutamide is almost always used)., LHRH monotherapy: buserelin acetate or leuprolide acetate.

1

Androgen suppression, radiotherapy, iodine 125 brachytherapy PROCEDURE

Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by iodine 125 brachytherapy carried out 14-25 days after the last external beam treatment.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically-proven prostate cancer stage T1c -T3a (UICC 1997).
• Patients with clinically organ-confined disease must meet the Canadian consensus definition of intermediate risk disease (i.e any one or more of: CS = T2b \[UICC1997 = bilateral palpable intra-capsular disease\], GS = 7, or iPSA \>10 and 20).
• Patients with Gleason sum 8 and/or PSA \> 20 must have a CT pelvis, and nuclear medicine bone scan showing no evidence of nodal (N0) or distant metastases (M0).
• Registration must occur within 36 weeks of biopsy.
• Patients with clinical or pathological evidence of seminal vesicle invasion (stage T3b) or involvement of adjacent pelvic organs/structures (stage T4) are not eligible.
• Pre-intervention PSA must not exceed 40 ng ml-1.
• Patients must have a chest x-ray and the following blood tests within four weeks of registration: PSA, PAP, testosterone, CBC, electrolytes, BUN, creatinine, AST, LDH and alkaline phosphatase. Patients with values for one or more of these tests that fall outside the normal range will not necessarily be ineligible, however, their eligibility will need to be reviewed by the study coordinator.
• Patients must have an ECG within four weeks of registration. Patients with ECGs judged to be significantly abnormal require a consultation with a cardiologist to ascertain their suitability for general or spinal anesthesia.
• Patients judged clinically to have a prostate volume \> 65 cm3 prior to starting androgen suppression must have a transrectal ultrasound for volume estimation. Patients with TRUS prostate volumes \> 75 cm3 prior to starting androgen suppression are not eligible for the study.
• Patients may have been started on neoadjuvant androgen suppression prior to registration provided:
• there is documentation of pre-treatment PSA and
• in the case of patients with iPSA \>20 and/or Gleason sum 8, a bone scan and CT pelvis were done prior to or within 4 weeks after starting neoadjuvant androgen suppression.
• Patients must not have received prior surgical treatment for prostate cancer including transurethral resection of the prostate (TURP), transurethral resection of the bladder neck (TURB), cryotherapy, laser ablation, or microwave therapy.
• Patients should have an estimated life expectancy of at least 5 years with an ECOG performance status of 0-2.
• Patients may not have received prior radiation therapy to the pelvis.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (3)

• Morris WJ, Pickles T, Keyes M. Using a surgical prostate-specific antigen threshold of >0.2 ng/mL to define biochemical failure for intermediate- and high-risk prostate cancer patients treated with definitive radiation therapy in the ASCENDE-RT randomized control trial. Brachytherapy. 2018 Nov-Dec;17(6):837-844. doi: 10.1016/j.brachy.2018.08.008. Epub 2018 Sep 21.

  PMID: 30245169 DERIVED

• Rodda S, Morris WJ, Hamm J, Duncan G. ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):581-589. doi: 10.1016/j.ijrobp.2017.02.027. Epub 2017 Feb 21.

  PMID: 28581398 DERIVED

• Rodda S, Tyldesley S, Morris WJ, Keyes M, Halperin R, Pai H, McKenzie M, Duncan G, Morton G, Hamm J, Murray N. ASCENDE-RT: An Analysis of Treatment-Related Morbidity for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost with a Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):286-295. doi: 10.1016/j.ijrobp.2017.01.008. Epub 2017 Jan 6.

  PMID: 28433432 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; nilutamide; bicalutamide; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• William J Morris, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2014
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)