Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate

NCT02064036 | Completed Phase 1 DMC

• 2 other identifiers: 421870CCRO025
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer. Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

Conditions

Adenocarcinoma of the Prostate

Keywords

Prostate Cancer; Radiotherapy; Androgen Deprivation

Outcome Measures

Primary Outcomes (1)

• Tumor Assessment

  Tumors will be assessed using the American Joint Committee on Cancer (AJCC) Staging System, 7th Edition. This system consists of the following subscales: the extent of the primary tumor (T category), whether the cancer has spread to nearby lymph nodes (N category), the absence or presence of distant metastasis (M category), the PSA level at the time of diagnosis, and the Gleason score, based on the prostate biopsy (or surgery).

  24 months

Secondary Outcomes (1)

• Zubrod Performance Scale

  Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy

Study Arms (1)

Single

EXPERIMENTAL

Neoadjuvant Androgen Blockade (Casodex) Followed by: Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade (Casodex and Leuprolide) to Whole Pelvis, Prostate, and Seminal VesiclesFollowed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance Followed by: Adjuvant Androgen Blockade (Casodex)

Radiation: Stereotactic Radiosurgical Boost; Drug: Casodex; Drug: Leuprolide

Interventions

Stereotactic Radiosurgical Boost RADIATION

Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance

Also known as: Intensity Modulated Radiotherapy (IMRT), Radiotherapy,, X-ray therapy, Irradiation

Single

Casodex DRUG

Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Also known as: Bicalutamide

Single

Leuprolide DRUG

Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Also known as: Goserelin

Single

Eligibility Criteria

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

You may qualify if:

• Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
• History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
• Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.
• Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.
• No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.
• Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
• Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.
• Study entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
• Zubrod Performance Status 0-2
• Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function
• Patient must be able to provide study specific informed consent prior to study entry.

You may not qualify if:

• Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• Previous hormonal therapy
• Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.
• Use of finasteride within 30 days prior to registration
• Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
• Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1.
• Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
• Severe, active co-morbidity including heart issues, infection and liver problems
• Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
• Prior allergic reaction to the hormones involved in this protocol
• Patients status-post a negative lymph node dissection are not eligible

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Sacramento Cancer Center Dept of Radiation Oncology

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy; X-Ray Therapy; Radiation; bicalutamide; Leuprolide; 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)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics; Physical Phenomena; 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

• Richard Valicenti, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: February 17, 2014
• Study Start: June 6, 2013
• Primary Completion: December 3, 2020
• Study Completion: October 29, 2021
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)