Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT)

NCT02594072 | Unknown DMC

• 1 other identifier: ASSERT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Two radiation therapy techniques are commonly used for the treatment of intermediate and high risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate, produces excellent outcomes but is invasive and not all patients are eligible or willing to receive this treatment. EBRT, while gentle at the time of delivery, tends to be very prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose radiation treatments. Treatments are short, non-invasive, applicable to patients not able to do brachytherapy, and may be more effective than conventional EBRT. This study will compare SABR with EBRT in terms of the rates of acute and late toxicities for each treatment, disease-free survival, and health-related quality of life measures.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of subjects experiencing treatment-related acute and late toxicities, focussing on grade 3 and 4 complications, as assessed by the NCI CTCAEv4 and modified RTOG/SOMA toxicity scale.

  5 years

Secondary Outcomes (3)

• Number of subjects with biochemical relapse free survival at five years as measured by PSA levels.

  5 years

• To compare the health related quality of life as reflected in changes on the EPIC questionnaire between the two interventions

  5 years

• To measure the mean prostate pre-fraction to post-fraction displacement, in millimeters, from CT scans done pre- and post-fraction.

  at week 5 of radiotherapy (completion of radiotherapy)

Study Arms (2)

SABR with androgen suppression

EXPERIMENTAL

Stereotactic ablative radiotherapy (SABR) with a prescribed dose of 36.25 Gy in 5 fractions over 5 weeks (one treatment day per week). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.

Radiation: stereotactic ablative radiotherapy; Drug: Zoladex ®

EBRT with androgen suppression

ACTIVE COMPARATOR

Conventional external beam radiation therapy (EBRT) with a prescribed dose of 73.68 Gy in 28 fractions (5 treatment days per week over 5.5 weeks). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.

Radiation: external beam radiation therapy; Drug: Zoladex ®

Interventions

stereotactic ablative radiotherapy RADIATION

Linac-based prostate stereotactic radiotherapy, using Volumetric Modulated Arc Therapy planning and delivery, with fiducial marker and cone-beam CT based image guidance.

SABR with androgen suppression

external beam radiation therapy RADIATION

Conventional intensity modulated radiotherapy, with fiducial marker or cone-beam CT based image guidance.

EBRT with androgen suppression

Zoladex ® DRUG

The preferred agent for the protocol is goserelin acetate (Zoladex ®) 3-month depot, but other LHRH agonists are permitted. The total duration of ADT will be 6 months for men with intermediate risk disease, and 18 months for those with high risk disease. ADT is to be initiated prior to the start of RT.

Also known as: goserelin acetate

EBRT with androgen suppression; SABR with androgen suppression

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of prostate cancer within 365 days prior to registration.
• Disease must be Canadian Consensus (GUROC) high and intermediate risk with probability of pelvic nodal involvements \<15% by the Updated Partin Tables.
• High risk is defined by any of: ≥T3a, PSA \> 20, or Gleason ≥ 8
• Intermediate risk is defined by: T1/T2 and/or Gleason ≤ 7 and/or PSA ≤20 and not low risk
• Disease must be T1 or T2 clinically
• Prostate specific antigen (PSA) and testosterone level (TTT) must be done not more than 60 days before registration. If androgen deprivation therapy is started before registration, PSA and TTT should be done not more than 60 days prior to commencement of androgen deprivation therapy.
• For high risk patients, negative pelvis CT scan and bone scan for metastases not more than 60 days before registration. If androgen deprivation therapy is started before registration, pelvis CT scan and bone scan should be done not more than 60 days prior to commencement of androgen deprivation therapy. For intermediate risk patients, pelvis CT scan and bone scan are optional.
• Commencement of androgen deprivation therapy is allowed before registration. However, the lead time must allow for completion of the radiation treatment within 6 months and 18 months of the androgen deprivation therapy treatment duration for intermediate and high risk disease respectively.
• History/physical examination with digital rectal examination of the prostate within 60 days of registration or commencement of androgen deprivation therapy.
• Life expectancy of at least 5 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• No contraindication for 6 months and 18 months of androgen deprivation therapy respectively for intermediate and high risk disease.

You may not qualify if:

• Clinical evidence of extra-prostatic disease extension
• Clinical evidence of prostate volume \> 90 cc prior to randomization
• Prior history of inflammatory bowel disease
• Prior history of invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
• Previous pelvic radiation
• Presence of a hip prosthesis
• Evidence of pelvic nodal involvement or distant metastases

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Cancer Agency: collaborator

Study Sites (2)

BC Cancer Agency Fraser Valley Center

Surrey, British Columbia, V3V1Z2, Canada

Location

BC Cancer Agency Vancouver Island Center

Victoria, British Columbia, V8R6V5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin

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)

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

• Abraham Alexander, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

• Winkle Kwan, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor, Radiation Oncologist

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 2, 2015
• Study Start: April 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CA (2)