Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00110162
• Other study ID #: PMCC-VCOG-PR-0103
• Secondary ID: CDR0000413706PMC
• Status: Recruiting
• Phase: Phase 3
• First received: May 3, 2005
• Last updated: August 6, 2013
• Start date: October 2004

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.

PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.

Description:

OBJECTIVES:

Primary

• Compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (ADT).

Secondary

• Compare cancer-specific survival of patients treated with these regimens.

• Compare clinical progression in patients treated with these regimens.

• Compare time to first androgen independence in patients treated with these regimens.

• Compare complication rate incidence and timing (e.g., cord compression or pathological failure) in patients treated with these regimens.

• Compare treatment-related morbidity (including cognitive morbidity or osteoporosis) in patients treated with these regimens.

• Compare quality of life of patients treated with these regimens.

• Determine prognostic factors for progression in patients treated with delayed ADT.

OUTLINE: This is a multicenter, randomized, controlled study. Patients in group 1 are stratified according to prior therapy (prostatectomy vs radiotherapy vs prostatectomy and radiotherapy), relapse-free interval (< 2 years vs ≥ 2 years), type of planned androgen deprivation therapy (ADT) (continuous vs intermittent), and participating center. Patients in group 2 are stratified according to type of planned ADT (continuous vs intermittent), disease type (localized vs metastatic), and participating center. Patients in both groups are randomized to 1 of 2 treatment arms.

• Arm I (delayed ADT): Beginning at least 2 years after study entry or after exhibiting evidence of significant disease progression*, patients receive either continuous ADT OR intermittent ADT comprising either bilateral orchiectomy OR luteinizing hormone-releasing hormone agonist with or without oral antiandrogen therapy.

• Arm II (immediate ADT): Beginning immediately after randomization, patients receive either continuous ADT OR intermittent ADT as in arm I.

NOTE: *Patients in group 1 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present: prostate-specific antigen (PSA) doubling time of < 12 months with PSA ≥ 10 ng/mL OR PSA doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart OR development of metastases or symptoms. Patients in group 2 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present: development of symptoms OR PSA ≥ 60 ng/mL OR PSA doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart.

After 9 months of ADT, all patients are assessed for response. Patients with PSA < 4 ng/mL may discontinue ADT. These patients are followed every 3 months. Treatment may be restarted when PSA is > 20 ng/mL OR PSA is > the PSA level at study entry OR at clinical progression.

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 3 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter at the discretion of the principal investigator.

PROJECTED ACCRUAL: A total of 300-2,000 patients will be accrued for this study within 2-5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Prostate-specific antigen (PSA) relapse OR incurable disease diagnosed within the past 2 months AND meets criteria for either of the following groups:

• Group 1

• In PSA relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following:

• Post-prostatectomy PSA level = 0.2 ng/mL

• At least 3 rising PSA levels (post-radiotherapy) obtained = 1 month apart, with the last PSA obtained within the past 2 months

• No metastatic disease by bone scan or abdomino-pelvic CT scan

• Group 2

• Not suitable for radical treatment at primary diagnosis

• Not planning to receive curative treatment

• Localized or metastatic disease

• No symptomatic disease requiring radiotherapy or immediate hormonal therapy

• No symptomatic disease requiring therapy

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Not specified

Life expectancy

• At least 5 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No other significant comorbid condition that would limit life expectancy to < 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• At least 12 months since prior androgen deprivation therapy (ADT) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1)

• No prior ADT (group 2)

Radiotherapy

• See Disease Characteristics

• See Endocrine therapy

Surgery

• See Disease Characteristics

Other

• No concurrent enrollment in TROG-96.01 or TROG-RADAR protocols

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• antiandrogen therapy

• releasing hormone agonist therapy

Procedure:
• orchiectomy

Locations

Country	Name	City	State
Australia	Urological Solutions	Ashford	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Cancer Therapy Centre at Campbelltown Hospital	Campbelltown	New South Wales
Australia	Christchurch Hospital	Christchurch
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Repatriation General Hospital	Daws Park	South Australia
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Geelong Hospital	Geelong	Victoria
Australia	Nepean Cancer Care Centre at Nepean Hospital	Kingswood	New South Wales
Australia	Cancer Therapy Centre at Liverpool Hospital	Liverpool	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	East Coast Cancer Centre	Tugun	Queensland
Australia	West Gippsland Hospital	Warragul	Victoria
Australia	Westmead Institute for Cancer Research at Westmead Hospital	Westmead	New South Wales
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Palmerston North Hospital	Palmerston North

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause at 8 years			No
Secondary	Cancer specific survival			No
Secondary	Clinical progression			No
Secondary	Time to first androgen independence			No
Secondary	Complication rate incidence and timing (e.g., cord compression, pathological fracture)			No
Secondary	Treatment-related morbidity (including cognitive, osteoporosis)			No
Secondary	Prognostic factors for progression (delayed group)			No
Secondary	EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years			No
Secondary	CTC v3.0 Survival endpoints: actuarial analysis at eight years			No
Secondary	Morbidity continuously			No