RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
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| ClinicalTrials.gov Identifier: NCT00541047 |
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Recruitment Status :
Completed
First Posted : October 8, 2007
Last Update Posted : November 13, 2023
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with androgen deprivation therapy may kill more prostate cancer cells.
PURPOSE: This randomized phase III trial is studying how well giving radiation therapy together with androgen deprivation therapy works in treating patients who have undergone surgery for prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastrointestinal Complications Prostate Cancer Sexual Dysfunction Urinary Complications | Drug: bicalutamide Drug: goserelin acetate Drug: leuprolide acetate Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
- Assess the timing of radiotherapy and the use of hormone therapy in conjunction with post-operative radiotherapy.
- Determine the impact of radiotherapy on general quality of life, sexual function, urinary function, and bowel function.
- Determine the impact of duration of hormone therapy on general quality of life and sexual function.
OUTLINE: This is a multicenter study. Patients requiring immediate radiotherapy (RT) are assigned to arm I; patients do not require immediate RT are assigned to arm II. Patients for whom the need of immediate post-operative radiotherapy are uncertain undergo radiotherapy timing randomization within 3 months after surgery and are randomized to 1 of 2 radiotherapy arms.
- Arm I (immediate RT): Within 2 months after randomization, patients undergo radiotherapy to the prostate bed once a day, 5 days a week, for 4 (20 fractions total) or 6.5 weeks (33 fractions total). They may also undergo radiotherapy to the pelvic lymph nodes once a day, 5 days a week, for 4.5 weeks (23 fractions total) at the investigator's discretion.
- Arm II (early salvage RT in case of PSA failure): Within 2 months of confirmation of post-operative biochemical failure, patients undergo radiotherapy as in arm I.
Patients undergoing immediate RT and patients who eventually need early salvage RT undergo hormone therapy duration randomization before the administration of post-operative radiotherapy. Patients are randomized to 1 of 3 hormone therapy arms.
- Arm III (no hormone therapy): Patients do not receive hormone therapy. They receive post-operative RT alone as described above in arm I or II.
- Arm IV (RT and short-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 6 months. Hormone therapy* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g., goserelin or leuprolide acetate]) or bicalutamide daily.
- Arm V (RT and long-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 24 months. Hormone therapy* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g., goserelin or leuprolide acetate]) or bicalutamide daily.
NOTE: *For Canadian patients, hormonal therapy will consist of LHRH analog (leuprolide acetate) therapy only.
Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed using self-administered questionnaires at baseline and 1, 5, and 10 years after randomization. Health economics information is also collected via patient-administered questionnaires (EQ-5D) at baseline and at 1, 5 and 10 years after randomization.
After completion of study treatment, patients are followed for 7 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4236 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS) |
| Study Start Date : | November 2007 |
| Actual Primary Completion Date : | July 27, 2022 |
| Actual Study Completion Date : | July 27, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: RADICALS-RT: Early RT |
Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
| Experimental: RADICALS-RT: Salvage RT |
Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
| Experimental: RADICALS-HD: Radiotherapy Alone |
Procedure: adjuvant therapy Radiation: radiation therapy |
| Experimental: RADICALS-HD: Radiotherapy + 6 months |
Drug: bicalutamide Drug: goserelin acetate Drug: leuprolide acetate Procedure: adjuvant therapy Radiation: radiation therapy |
| Experimental: RADICALS-HD: Radiotherapy + 24 months |
Drug: bicalutamide Drug: goserelin acetate Drug: leuprolide acetate Procedure: adjuvant therapy Radiation: radiation therapy |
- Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD) [ Time Frame: up 12 years ]
- Freedom from distant metastases (any distance metastases or prostate cancer death) (RADICALS-RT) [ Time Frame: up 12 years ]
- Freedom from treatment failure [ Time Frame: up 12 years ]
- Clinical progression-free survival [ Time Frame: up 12 years ]
- Overall survival [ Time Frame: up 12 years ]
- Non-protocol hormone therapy [ Time Frame: up 12 years ]
- Treatment toxicity [ Time Frame: up 12 years ]
- Patient reported outcomes - EQ5D [ Time Frame: up 12 years ]
- Freedom from biochemical progression (RADICALS-RT) [ Time Frame: up 12 years ]
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| Ages Eligible for Study: | 0 Years to 120 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
- Diagnosis of nonmetastatic adenocarcinoma of the prostate
- Must have undergone radical prostatectomy
- Post-operative serum prostate-specific antigen (PSA) < 0.4 ng/mL
- No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)
Exclusion criteria:
- Known distant metastases from prostate cancer
- PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)
PATIENT CHARACTERISTICS:
- No other active malignancy likely to interfere with protocol treatment or follow-up
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- See Disease Characteristics
- Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
- 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies
Exclusion criteria:
- Prior hormone therapy
- Bilateral orchidectomy
- Prior pelvic radiotherapy
- Neoadjuvant treatment
- Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541047
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| Study Chair: | Christopher Parker, MD | Royal Marsden NHS Foundation Trust |
| Responsible Party: | Cheryl Pugh, Clinical Project Manager, University College, London |
| ClinicalTrials.gov Identifier: | NCT00541047 |
| Other Study ID Numbers: |
CDR0000571528 MRC-RADICALS-PR10 ( Other Identifier: MRC at UCL ) ISRCTN40814031 ( Registry Identifier: ISRCTN ) 2006-000205-34 ( EudraCT Number ) 00316/0223/001-0001 ( Other Identifier: CTA ) PR13 ( Other Grant/Funding Number: Canadian Cancer Society - Research Institute ) |
| First Posted: | October 8, 2007 Key Record Dates |
| Last Update Posted: | November 13, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Data can be shared on request via emailing mrcctu.radical@ucl.ac.uk |
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sexual dysfunction urinary complications gastrointestinal complications adenocarcinoma of the prostate |
stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Leuprolide |
Goserelin Bicalutamide Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |