Post-operative or Early Salvage XRT and ADT for High Risk PCa

NCT00949962 | Terminated Phase 3 DMC

• 3 other identifiers: EORTC-22043-30041EU-209502006-002772-17
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective when given together with or without hormone therapy in treating patients with prostate cancer who have undergone surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with hormone therapy in treating patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical progression-free survival

Secondary Outcomes (5)

• Clinical progression-free survival

• Distant-metastases-free survival

• Overall survival

• Quality of life as assessed by QLQ-C30 and QLQ-PR25 at baseline and at 6 months, 1 year, 2 years, and 5 years after treatment

• Acute and late toxicity according to NCI CTCAE version 3.0

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.

Radiation: 3-dimensional conformal radiation therapy

Arm II

EXPERIMENTAL

Beginning on day -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.

Drug: antiandrogen therapy; Drug: leuprolide acetate; Radiation: 3-dimensional conformal radiation therapy

Interventions

antiandrogen therapy DRUG

Given systemically

Arm II

leuprolide acetate DRUG

Given subcutaneously

Arm II

3-dimensional conformal radiation therapy RADIATION

Undergo radiotherapy

Arm I; Arm II

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of prostate cancer * Clinical stage cT1-2-3a, N0, M0 disease pre-operatively * Pre-operative PSA ≤ 5 x upper limit of normal * Presenting the following conditions after radical prostatectomy: * Gleason sum 5-10 * Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section \> 2 mm) or pT3a-b (irrespective of margin status) * Negative lymph node (LN) status (pN0) by LN sampling or LN dissection * Unknown pathological LN status is not allowed, except for disease classified as cT ≤ cT1c with baseline PSA ≤ 10 ng/mL, Gleason score \< 7, and ≥ 12 positive core biopsies \< 50% * Undetectable post-operative PSA within 3 months of surgery PATIENT CHARACTERISTICS: * WHO performance status 0-1 * WBC ≥ 3 x 10\^9/L * Hemoglobin ≥ 110 g/L * Platelet count ≥ 100 x 10\^9/L * No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 5 years since prior chemotherapy * No prior pelvic irradiation * No prior bilateral orchiectomy * No prior hormonal treatment except neoadjuvant treatment lasting ≤ 3 months * No other concurrent anticancer agent or modality

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

European Organization for Research and Treatment of Cancer

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Leuprolide; Radiotherapy, Conformal

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)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Michel Bolla, MD

  CHU de Grenoble - Hopital de la Tronche

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 4, 2014

Record last verified: 2014-07

Locations

FR (1)